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Cabozantinib Treatment in a Phase II Study for Patients With Hepatocellular Carcinoma (HCC) Refractory to PD-1 Inhibitors (CaPture)

Primary Purpose

Hepatocellular Carcinoma

Status
Recruiting
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Cabozantinib
Sponsored by
University of Leipzig
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring HCC, Cabozantinib, PD-1 inhibitor, PD-L1 inhibitor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients with diagnosis of locally advanced or metastatic and/or unresectable hepatocellular carcinoma (HCC)
  2. Pre-Treatment with a PD-1/PD-L1 inhibitor for at least one administration which was given as first line or as following line systemic treatment alone or in combination with other systemic or local treatments (e.g. TACE)
  3. Disease progression or end of therapy due to toxicity during/after pre-therapy
  4. CTCAE ≤ Grade 2 prior to study registration, with the exception of alopecia
  5. ECOG (Eastern Cooperative of Onco-logy Group) Index 0 or 1
  6. Age ≥ 18 years
  7. Written informed consent

Exclusion Criteria:

  1. Significant portal hypertension (moderate or severe ascites)
  2. No adequate controlled arterial hypertension (RR > 140/80mmHg)
  3. ALAT/ASAT five times higher then upper normal value
  4. Hepatic encephalopathy (every stage)
  5. Liver cirrhosis Child-Pugh B and C
  6. Known fibrolamellar HCC, sarcomatoid HCC, or cholangiocarcinoma mixed with HCC
  7. Major surgical procedure, other than for diagnosis, within eight weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study
  8. Severe infection with alteration of general condition within four weeks prior to initiation of study treatment
  9. Severely impaired kidney function (CDK: stadium 4: GFR<30)
  10. Myocardial infarction within 12 months prior to initiation of study treatment
  11. Epilepsy
  12. Heart failure, Cardiac arrhythmia, respectively long-QT syndrome
  13. Severe bleeding or high risk for the development of severe bleeding, including esophageal varices > 1° or esophageal varices with red marks as seen on a lighted stomach scope (endoscopy)
  14. Chronic inflammatory bowel disease (e.g. colitis ulcerosa, diverticulitis, Crohn's disease)
  15. Increased risk of thromboembolism due to medical history or disease
  16. Significant alcohol consumption (>1 drink/day; 1 drink=0.25l beer or 0,1l wine or 2cl spirituous beverages)
  17. Known active HIV infection
  18. Known hereditary galactose intolerance, lactase deficiency, glucose-galactose malabsorption
  19. Prior Cabozantinib use
  20. Ongoing therapy with direct oral anticoagulants (DOAK) / platelet aggregation inhibitor or statine (e.g. Ticagrelor, Clopidogrel)
  21. Predicted life expectancy of less than 6 months
  22. Female patients who do not meet at least one of the following criteria:

    • Postmenopausal women (for at least 1 year before the screening visit) OR
    • Postoperative status (6 weeks after bilateral ovariectomy with or without hysterectomy) OR
    • If they are of childbearing potential, agree to practice one highly effective method of contraception and one additional effective (barrier) method at the same time, from the time of signing the informed consent through 4 months after the last dose of study drug, OR
    • Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together.) OR
    • Abstinence OR
    • Vasectomy of the partner
  23. Male patients not using one of the following variants for contraception including a period of 4 months after the completion of the therapy:

    • Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. OR
    • Condition after vasectomy OR
    • Condom
  24. Participation in any other interventional trials within 28 days prior to initiation of study treatment
  25. Suspected lack of compliance to previous treatments; inability to take the medication
  26. Pregnancy or lactation, or intention of becoming pregnant during study treatment

Sites / Locations

  • Technische Universität Dresden, Medizinische Fakultät Carl Gustav Carus Medizinische Klinik und Poliklinik IRecruiting
  • University Hospital LeipzigRecruiting
  • Charite Universitätsmedizin, Campus Virchow Klinikum, Klinik für Hepatologie/GastroenterologieRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Cabozantinib

Arm Description

Enrolled patients start with 60mg of Cabozantinib. The maximum duration of treatment is 336 days. The dose can be adjusted by the physician to 40mg or 20mg.

Outcomes

Primary Outcome Measures

time on treatment (TT)
Primary endpoint of the trial is the time on treatment (TT). TT is defined as one plus the last date of treatment with Cabozantinib minus the first date of treatment with Cabozantinib, and will be measured in days (note that Cabozantinib will be administered as a single dose per day). The end of treatment must be confirmed by the investigator. In particular, planned discontinuations or missing compliance will not be considered as end of treatment without confirmation.

Secondary Outcome Measures

Overall survival (OS)
Overall survival (OS), is the time to death of any cause. OS is measured in days, defined as death date minus registration date.
Progression-free survival (PFS)
Progression-free survival (PFS) is the time to tumor progression or death of any cause, whichever comes first. PFS is measured in days, defined as date of diagnosis of tumor progression by mRECIST criteria minus registration date. If a patient dies without previous diagnosis of tumor progression, date of diagnosis is replaced by death date.
Duration of response (DoR)
is the time from achievement of response (i.e., measurement criteria for CR or PR are first met, cf. Eisenhauer et al., 2009, p. 236) until the first date that tumor recurrence or progression is documented (taking as reference the smallest measurements recorded in the study) or death of any cause, whichever comes first. DoR is measured in days, defined as date of documentation of tumor progression by mRECIST criteria minus date of documentation of tumor response (CR or PR). If a patient dies without previous diagnosis of tumor progression, date of progression documentation is to be replaced by death date. If CR or PR will never be documented for a patient, DoR is set to "zero".
Response rates
Response rates, measured in percent, are defined as the number of patients whose best tumor response observed by mRECIST criteria is CR, PR, SD or PD, respectively, divided by the total number of registered patients. The overall response rate (ORR) is defined as the number of patients whose best tumor response observed by mRECIST criteria is CR or PR divided by the total number of registered patients.
Median average dose
Median average dose, measured in milligram (mg). Averages of all Cabozantinib doses administered will be calculated weekly from first date of treatment until end of treatment. Discontinuations of treatment for any reason, including missing compliance, will be included into this calculation as zero doses. Median average dose is defined as the median of the obtained sequence of averages.
Image-based endpoint: Tumor progression
Tumor progression, assessed at Visits 3, 6, 9, 12 and EoT visit (if applicable) in comparison to the state at Screening, by mRECIST criteria.
Image-based endpoint: Progression of tumoral macrovascular invasion
Progression of tumoral macrovascular invasion of hepatic and/or portal vein branches, assessed at Visits 3, 6, 9, 12 and EoT visit (if applicable) according to the working instruction for radiologists, in comparison to state at Screening.
Image-based endpoint: Progression of extrahepatic HCC manifestations
Progression of extrahepatic HCC manifestations, assessed at Visits 3, 6, 9, 12 and EoT visit (if applicable) according to the working instruction for radiologists, in comparison to state at Screening.
Image-based endpoint: Total tumor volume
Total tumor volume (TTV), assessed at Screening, Visits 3, 6, 9, 12 and EoT visit (if applicable), measured in cm^3 according to the working instruction for radiologists.
Image-based endpoint: Affection rate
Affection rate, assessed at Screening, Visits 3, 6, 9, 12 and EoT visit (if applicable), measured in percent. Affection rate is defined as total tumor volume divided by total liver volume, both measured in cm^3 according to the working instruction for radiologists.
Concentration of Alpha-fetoprotein (AFP),
Concentration of Alpha-fetoprotein (AFP), measured in µg/l, at Screening and Visits 0, 3, 6, 9, 12 and EoT visit (if applicable).
Child-Pugh classification score
Child-Pugh classification score, measured in levels from A to C, at Screening and Visits 3, 6, 9, 12, EoT and FU1 (if applicable).
ECOG Performance Status
ECOG Performance Status, measured in levels from 0 to 5, at Screening and Visits 3, 6, 9, 12, EoT and FU1 (if applicable).
drug-related interruption, reduction or termination of treatment (safety endpoint)
Descriptive documentation
occurence of clinical symptoms of liver dysfunction (safety endpoint)
Descriptive documentation

Full Information

First Posted
January 8, 2021
Last Updated
March 10, 2022
Sponsor
University of Leipzig
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1. Study Identification

Unique Protocol Identification Number
NCT04767906
Brief Title
Cabozantinib Treatment in a Phase II Study for Patients With Hepatocellular Carcinoma (HCC) Refractory to PD-1 Inhibitors
Acronym
CaPture
Official Title
Cabozantinib Treatment in a Phase II Study for Patients With Hepatocellular Carcinoma (HCC) Refractory to PD-1 Inhibitors
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Recruiting
Study Start Date
December 14, 2021 (Actual)
Primary Completion Date
June 14, 2024 (Anticipated)
Study Completion Date
December 14, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Leipzig

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The CaPture trial is a prospective, multi-centre, non-randomized phase II study. Its aim is to assess feasibility, safety and efficacy signals of Cabozantinib treatment in patients with HCC and prior non-response or disease progression during a PD-1 or PD-L1 inhibitor treatment. Since the potential study population is very small, the sample size has been fixed in advance to N = 40. Time on treatment (TT) will be measured as primary endpoint.
Detailed Description
Patients will be recruited at the participating trial sites (up to ten trial sites), which are all specialized in treatment of patients with HCC. Once potential patients are identified by trial physicians, they will be asked for trial participation and informed consent by one investigator of the CaPture trial. Patients included within 4 weeks after diagnosis of failure of preceding PD-1/PD-L1 inhibitory treatment. After baseline, visits are previewed on a 4weekly (28 days) basis during the whole duration of Cabozantinib study treatment, which can be used for a maximum of 12 months (336 days). The treatment with Cabozantinib will be performed in accordance with the valid license and according to the judgement of the treating physician.The tablet is taken once a day, starting normally with the highest dosage (60 mg). The doses 20mg and 40mg are still available and can be used for dose reduction. During the visits, the patient will be questioned for compliance and side effects and examined for clinical and laboratory parameters. Response to Cabozantinib should be assessed at least every 12 weeks (84 days) by either CT scan or MRI. After termination of Cabozantinib study treatment the first follow-up visit takes place one month after the end of therapy in person. Further follow-up visits can be done by phone to collect patient's status and further treatment. In addition to the time on treatment (TT), survival, response, feasibility, biomarkers, health status and safety should also be tested. Furthermore there is an concomitant scientific project. The aim of this project is to examinate the association of HCC related biomarkers with response to Cabozantinib in patients treated in the CaPture study. For this, we will analyse liver biopsy samples as well as circulating markers in patients who are willing to participate in the project.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
HCC, Cabozantinib, PD-1 inhibitor, PD-L1 inhibitor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Patients with hepatocellular carcinoma with prior non-response or disease progression during a PD-1 or PD-L1 inhibitor treatment will be treated with Cabozantinib.
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cabozantinib
Arm Type
Other
Arm Description
Enrolled patients start with 60mg of Cabozantinib. The maximum duration of treatment is 336 days. The dose can be adjusted by the physician to 40mg or 20mg.
Intervention Type
Drug
Intervention Name(s)
Cabozantinib
Intervention Description
The medication is taken once a day for 336 days (max.). The start dose is 60mg and can be reduced according to the physicians decision. 40mg and 20mg are also available.
Primary Outcome Measure Information:
Title
time on treatment (TT)
Description
Primary endpoint of the trial is the time on treatment (TT). TT is defined as one plus the last date of treatment with Cabozantinib minus the first date of treatment with Cabozantinib, and will be measured in days (note that Cabozantinib will be administered as a single dose per day). The end of treatment must be confirmed by the investigator. In particular, planned discontinuations or missing compliance will not be considered as end of treatment without confirmation.
Time Frame
start of treatment until end of treatment (max. 336 days)
Secondary Outcome Measure Information:
Title
Overall survival (OS)
Description
Overall survival (OS), is the time to death of any cause. OS is measured in days, defined as death date minus registration date.
Time Frame
screening visit until date of death, maximum until the last registered patient reached the second follow-up (6 months after end of therapy)
Title
Progression-free survival (PFS)
Description
Progression-free survival (PFS) is the time to tumor progression or death of any cause, whichever comes first. PFS is measured in days, defined as date of diagnosis of tumor progression by mRECIST criteria minus registration date. If a patient dies without previous diagnosis of tumor progression, date of diagnosis is replaced by death date.
Time Frame
screening visit until the time to tumor progression or date of death from any cause, whichever came first, maximum until the last registered patient reached the second follow-up (6 months after end of therapy)
Title
Duration of response (DoR)
Description
is the time from achievement of response (i.e., measurement criteria for CR or PR are first met, cf. Eisenhauer et al., 2009, p. 236) until the first date that tumor recurrence or progression is documented (taking as reference the smallest measurements recorded in the study) or death of any cause, whichever comes first. DoR is measured in days, defined as date of documentation of tumor progression by mRECIST criteria minus date of documentation of tumor response (CR or PR). If a patient dies without previous diagnosis of tumor progression, date of progression documentation is to be replaced by death date. If CR or PR will never be documented for a patient, DoR is set to "zero".
Time Frame
screening visit until the time from achievement of response or date of death from any cause, whichever came first, maximum until the last registered patient reached the second follow-up (6 months after end of therapy)
Title
Response rates
Description
Response rates, measured in percent, are defined as the number of patients whose best tumor response observed by mRECIST criteria is CR, PR, SD or PD, respectively, divided by the total number of registered patients. The overall response rate (ORR) is defined as the number of patients whose best tumor response observed by mRECIST criteria is CR or PR divided by the total number of registered patients.
Time Frame
screening visit until end of treatment (max. 336 days)
Title
Median average dose
Description
Median average dose, measured in milligram (mg). Averages of all Cabozantinib doses administered will be calculated weekly from first date of treatment until end of treatment. Discontinuations of treatment for any reason, including missing compliance, will be included into this calculation as zero doses. Median average dose is defined as the median of the obtained sequence of averages.
Time Frame
start of treatment until end of treatment (max. 336 days)
Title
Image-based endpoint: Tumor progression
Description
Tumor progression, assessed at Visits 3, 6, 9, 12 and EoT visit (if applicable) in comparison to the state at Screening, by mRECIST criteria.
Time Frame
screening until end of treatment (max. 336 days)
Title
Image-based endpoint: Progression of tumoral macrovascular invasion
Description
Progression of tumoral macrovascular invasion of hepatic and/or portal vein branches, assessed at Visits 3, 6, 9, 12 and EoT visit (if applicable) according to the working instruction for radiologists, in comparison to state at Screening.
Time Frame
screening until end of treatment (max. 336 days)
Title
Image-based endpoint: Progression of extrahepatic HCC manifestations
Description
Progression of extrahepatic HCC manifestations, assessed at Visits 3, 6, 9, 12 and EoT visit (if applicable) according to the working instruction for radiologists, in comparison to state at Screening.
Time Frame
screening until end of treatment (max. 336 days)
Title
Image-based endpoint: Total tumor volume
Description
Total tumor volume (TTV), assessed at Screening, Visits 3, 6, 9, 12 and EoT visit (if applicable), measured in cm^3 according to the working instruction for radiologists.
Time Frame
screening until end of treatment (max. 336 days)
Title
Image-based endpoint: Affection rate
Description
Affection rate, assessed at Screening, Visits 3, 6, 9, 12 and EoT visit (if applicable), measured in percent. Affection rate is defined as total tumor volume divided by total liver volume, both measured in cm^3 according to the working instruction for radiologists.
Time Frame
screening until end of treatment (max. 336 days)
Title
Concentration of Alpha-fetoprotein (AFP),
Description
Concentration of Alpha-fetoprotein (AFP), measured in µg/l, at Screening and Visits 0, 3, 6, 9, 12 and EoT visit (if applicable).
Time Frame
screening until end of treatment (max. 336 days)
Title
Child-Pugh classification score
Description
Child-Pugh classification score, measured in levels from A to C, at Screening and Visits 3, 6, 9, 12, EoT and FU1 (if applicable).
Time Frame
screening until first follow-up (one month after EoT)
Title
ECOG Performance Status
Description
ECOG Performance Status, measured in levels from 0 to 5, at Screening and Visits 3, 6, 9, 12, EoT and FU1 (if applicable).
Time Frame
screening until first follow-up (one month after EoT)
Title
drug-related interruption, reduction or termination of treatment (safety endpoint)
Description
Descriptive documentation
Time Frame
start of treatment until end of treatment (max. 336 days)
Title
occurence of clinical symptoms of liver dysfunction (safety endpoint)
Description
Descriptive documentation
Time Frame
start of treatment until end of treatment (max. 336 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with diagnosis of locally advanced or metastatic and/or unresectable hepatocellular carcinoma (HCC) Pre-Treatment with a PD-1/PD-L1 inhibitor for at least one administration which was given as first line or as following line systemic treatment alone or in combination with other systemic or local treatments (e.g. TACE) Disease progression or end of therapy due to toxicity during/after pre-therapy CTCAE ≤ Grade 2 prior to study registration, with the exception of alopecia ECOG (Eastern Cooperative of Onco-logy Group) Index 0 or 1 Age ≥ 18 years Written informed consent Exclusion Criteria: Significant portal hypertension (moderate or severe ascites) No adequate controlled arterial hypertension (RR > 140/80mmHg) ALAT/ASAT five times higher then upper normal value Hepatic encephalopathy (every stage) Liver cirrhosis Child-Pugh B and C Known fibrolamellar HCC, sarcomatoid HCC, or cholangiocarcinoma mixed with HCC Major surgical procedure, other than for diagnosis, within eight weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study Severe infection with alteration of general condition within four weeks prior to initiation of study treatment Severely impaired kidney function (CDK: stadium 4: GFR<30) Myocardial infarction within 12 months prior to initiation of study treatment Epilepsy Heart failure, Cardiac arrhythmia, respectively long-QT syndrome Severe bleeding or high risk for the development of severe bleeding, including esophageal varices > 1° or esophageal varices with red marks as seen on a lighted stomach scope (endoscopy) Chronic inflammatory bowel disease (e.g. colitis ulcerosa, diverticulitis, Crohn's disease) Increased risk of thromboembolism due to medical history or disease Significant alcohol consumption (>1 drink/day; 1 drink=0.25l beer or 0,1l wine or 2cl spirituous beverages) Known active HIV infection Known hereditary galactose intolerance, lactase deficiency, glucose-galactose malabsorption Prior Cabozantinib use Ongoing therapy with direct oral anticoagulants (DOAK) / platelet aggregation inhibitor or statine (e.g. Ticagrelor, Clopidogrel) Predicted life expectancy of less than 6 months Female patients who do not meet at least one of the following criteria: Postmenopausal women (for at least 1 year before the screening visit) OR Postoperative status (6 weeks after bilateral ovariectomy with or without hysterectomy) OR If they are of childbearing potential, agree to practice one highly effective method of contraception and one additional effective (barrier) method at the same time, from the time of signing the informed consent through 4 months after the last dose of study drug, OR Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together.) OR Abstinence OR Vasectomy of the partner Male patients not using one of the following variants for contraception including a period of 4 months after the completion of the therapy: Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. OR Condition after vasectomy OR Condom Participation in any other interventional trials within 28 days prior to initiation of study treatment Suspected lack of compliance to previous treatments; inability to take the medication Pregnancy or lactation, or intention of becoming pregnant during study treatment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicole Köppe-Bauernfeind
Phone
+493419716266
Email
nicole.koeppe-bauernfeind@zks.uni-leipzig.de
First Name & Middle Initial & Last Name or Official Title & Degree
Florian van Bömmel, MD
Phone
+493419712436
Email
florian.vanboemmel@medizin.uni-leipzig.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Florian van Bömmel, MD
Organizational Affiliation
Authorised representative of the sponsor (University of Leipzig)
Official's Role
Study Chair
Facility Information:
Facility Name
Technische Universität Dresden, Medizinische Fakultät Carl Gustav Carus Medizinische Klinik und Poliklinik I
City
Dresden
State/Province
Saxonia
ZIP/Postal Code
01307
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susann Kempe
Phone
+49 351 458 7683
Email
oncostudy@uniklinikum-dresden.de
First Name & Middle Initial & Last Name & Degree
Jeanette Stephan
Phone
+49 351 458 7683
Email
oncostudy@uniklinikum-dresden.de
First Name & Middle Initial & Last Name & Degree
Gunnar Folprecht, MD
First Name & Middle Initial & Last Name & Degree
Anke Kröcher, MD
Facility Name
University Hospital Leipzig
City
Leipzig
State/Province
Saxonia
ZIP/Postal Code
04103
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Florian van Bömmel, Dr.
Phone
+49 341 97 12330
Email
Florian.vanBoemmel@medizin.uni-leipzig.de
First Name & Middle Initial & Last Name & Degree
Thomas Berg, Prof. Dr.
Phone
+49 341 97 12330
Email
thomas.berg@medizin.uni-leipzig.de
First Name & Middle Initial & Last Name & Degree
Thomas Berg, MD
First Name & Middle Initial & Last Name & Degree
Floraian van Bömmel, MD
Facility Name
Charite Universitätsmedizin, Campus Virchow Klinikum, Klinik für Hepatologie/Gastroenterologie
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marco Kanter
Phone
+49 30 450 630074
Email
marco.kanter@charite.de
First Name & Middle Initial & Last Name & Degree
Markus Reiß
Phone
+49 30 450 66 53 18
Email
markus.reiss@charite.de
First Name & Middle Initial & Last Name & Degree
Raphael Mohr, MD
First Name & Middle Initial & Last Name & Degree
Frank Tacke, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
After publication of the major results and upon reasonable request from researchers performing an individual patient data meta-analysis, individual patient data underlying published results will be shared after re-identification. This requires approval by the local Institutional Review Board (IRB) of the researcher requesting the data along with public registration of the meta-analysis.
IPD Sharing Time Frame
After publication of the major results.
IPD Sharing Access Criteria
Individual patient data underlying published results will be shared after re-identification. This requires approval by the local Institutional Review Board (IRB) of the researcher requesting the data along with public registration of the meta-analysis.

Learn more about this trial

Cabozantinib Treatment in a Phase II Study for Patients With Hepatocellular Carcinoma (HCC) Refractory to PD-1 Inhibitors

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