Back to resultsSurufatinib and Sintilimab in Combination With Capecitabine for Metastatic Adenocarcinoma of Small Intestine or Appendix Carcinoma
Primary Purpose
Adenocarcinoma of Small Intestine, Appendix Carcinoma, Metastatic
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Surufatinib
Sintilimab
Capecitabine
Sponsored by
About this trial
This is an interventional treatment trial for Adenocarcinoma of Small Intestine
Eligibility Criteria
Inclusion Criteria:
- Histological or cytological documentation of adenocarcinoma of Small Intestine or Appendix Carcinoma. All other histological types are excluded.
- Subjects with metastatic adenocarcinoma of Small Intestine or Appendix Carcinoma.
- Subjects must have failed at least one line of prior treatment.
- Progression during or within 3 months following the last administration of approved standard therapies . 4.1 Subjects an adjuvant setting should have progressed during or within 6 months of completion of adjuvant therapy. 4.2 Subjects who have withdrawn from standard treatment due to unacceptable toxicity warranting discontinuation of treatment and precluding retreatment with the same agent prior to progression of disease will also be allowed into the study. 4.3 Subjects may have received prior treatment with Avastin (bevacizumab)
- Subjects must have measurable or non measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria, version 1.1.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 1.
- Life expectancy of at least 3 months.
- Adequate bone marrow, liver and renal function as assessed by the laboratory required by protocol.
Exclusion Criteria:
- Prior treatment with Surufatinib
- Previously received anti-programmed death-1 (PD-1) or its ligand (PD-L1) antibody, anti-cytotoxic T lymphocyte-associated antigen 4 (cytotoxic T- lymphocyte-associated Protein 4, CTLA-4) antibody or other drug/antibody that acts on T cell costimulation or checkpoint pathways.
- Previous or concurrent cancer that is distinct in primary site or histology from colorectal cancer within 5 years prior to randomization EXCEPT for curatively treated cervical cancer in situ, non-melanoma skin cancer and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor invades lamina propria)].
- Cardiological disease including Congestive heart failure, Unstable angina, Myocardial infarction, Cardiac arrhythmias requiring anti-arrhythmic therapy.
- Uncontrolled hypertension. (Systolic blood pressure 150 mmHg or diastolic pressure 90 mmHg despite optimal medical management).
- Pleural effusion or ascites that causes respiratory compromise. Arterial or venous thrombotic or embolic events.
- Any history of or currently known brain metastases.
- Interstitial lung disease with ongoing signs and symptoms at the time of informed consent.
- Systemic anticancer therapy including cytotoxic therapy, signal transduction inhibitors, immunotherapy, and hormonal therapy during this trial or within 4 week.
Sites / Locations
- The Sixth Affiliated Hospital of Sun Yat-sen UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Surufatinib and Sintilimab in Combination With Capecitabine
Arm Description
Patients were given solventinib (a "3+3" design was adopted in the dose exploration phase, with two dose levels of 200mg and 250mg for dose exploration; after the recommended dose was determined in the dose exploration phase, the dose amplification phase was entered), once a day (QD) for continuous administration sindilizumab, 200mg, iv every 3 weeks (Q3W) Capecitabine, 1000mg/m2, twice a day (BID, once in the morning and once in the evening), orally after meals, stopped for 1 week after 2 weeks of treatment; The three-drug combination therapy was continued every 3 weeks in a cycle until patients developed disease progression or met other criteria for termination of study treatment specified in the protocol.
Outcomes
Primary Outcome Measures
Progression-free survival (PFS)
The PFS is defined as the time from the start of treatment to the date of first documented PD or death as a result of any cause, whichever occurred first. When a patient was alive and without progression, PFS was censored at the date of the last disease assessment.
Secondary Outcome Measures
Objective response rate (ORR)
The percentage of subjects with total number of Complete Response (CR) + total number of Partial Response (PR).
Overall Survival (OS)
OS is defined as the time from date of randomization to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact.
Disease Control Rate (DCR)
DCR is defined as the percentage of subjects whose best response was not Progressive Disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) (= total number of Complete Response (CR) + total number of Partial Response (PR) + total number of Stable Disease (SD); CR, PR, or SD had to be maintained for at least 28 days from the first demonstration of that rating)
Safety variables (Incidence of Adverse Events [Safety and Tolerability])
Safety variables will be summarized using descriptive statistics based on adverse events collection
Full Information
NCT ID
NCT05472948
First Posted
July 22, 2022
Last Updated
February 25, 2023
Sponsor
Sun Yat-sen University
1. Study Identification
Unique Protocol Identification Number
NCT05472948
Brief Title
Surufatinib and Sintilimab in Combination With Capecitabine for Metastatic Adenocarcinoma of Small Intestine or Appendix Carcinoma
Official Title
Surufatinib and Sintilimab in Combination With Capecitabine in Patients With Previously Treated Metastatic Adenocarcinoma of Small Intestine or Appendix Carcinoma : a Single-arm, a Single-center , Phase 2 Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
November 30, 2024 (Anticipated)
Study Completion Date
November 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To explore the safety and efficacy of Surufatinib and Sintilimab in Combination With Capecitabine in Patients With Previously Treated Metastatic Adenocarcinoma of Small Intestine or Appendix Carcinoma : a Single-arm, a Single-center , Phase 2 Trial. Meanwhile, Exploring the maximum tolerant dose or recommended II research dose of Surufatinib combined with a fixed dose of Sintilimab and Capecitabine using 3 + 3 dose climbing experiment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenocarcinoma of Small Intestine, Appendix Carcinoma, Metastatic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Surufatinib and Sintilimab in Combination With Capecitabine
Arm Type
Experimental
Arm Description
Patients were given solventinib (a "3+3" design was adopted in the dose exploration phase, with two dose levels of 200mg and 250mg for dose exploration; after the recommended dose was determined in the dose exploration phase, the dose amplification phase was entered), once a day (QD) for continuous administration
sindilizumab, 200mg, iv every 3 weeks (Q3W)
Capecitabine, 1000mg/m2, twice a day (BID, once in the morning and once in the evening), orally after meals, stopped for 1 week after 2 weeks of treatment;
The three-drug combination therapy was continued every 3 weeks in a cycle until patients developed disease progression or met other criteria for termination of study treatment specified in the protocol.
Intervention Type
Drug
Intervention Name(s)
Surufatinib
Other Intervention Name(s)
SULANDA
Intervention Description
Surufatinib will be given 200/250 mg po. qd.
Intervention Type
Drug
Intervention Name(s)
Sintilimab
Other Intervention Name(s)
IBI308
Intervention Description
Sintilimab administered IV at a dose of 200mg every 3 weeks.
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Other Intervention Name(s)
Capecitabine tablets
Intervention Description
Capecitabine will be given 2 weeks on/1 week off (1000 mg/m2 BID po.)
Primary Outcome Measure Information:
Title
Progression-free survival (PFS)
Description
The PFS is defined as the time from the start of treatment to the date of first documented PD or death as a result of any cause, whichever occurred first. When a patient was alive and without progression, PFS was censored at the date of the last disease assessment.
Time Frame
2 year
Secondary Outcome Measure Information:
Title
Objective response rate (ORR)
Description
The percentage of subjects with total number of Complete Response (CR) + total number of Partial Response (PR).
Time Frame
2 year
Title
Overall Survival (OS)
Description
OS is defined as the time from date of randomization to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact.
Time Frame
2 year
Title
Disease Control Rate (DCR)
Description
DCR is defined as the percentage of subjects whose best response was not Progressive Disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) (= total number of Complete Response (CR) + total number of Partial Response (PR) + total number of Stable Disease (SD); CR, PR, or SD had to be maintained for at least 28 days from the first demonstration of that rating)
Time Frame
2 year
Title
Safety variables (Incidence of Adverse Events [Safety and Tolerability])
Description
Safety variables will be summarized using descriptive statistics based on adverse events collection
Time Frame
2 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histological or cytological documentation of adenocarcinoma of Small Intestine or Appendix Carcinoma. All other histological types are excluded.
Subjects with metastatic adenocarcinoma of Small Intestine or Appendix Carcinoma.
Subjects must have failed at least one line of prior treatment.
Progression during or within 3 months following the last administration of approved standard therapies . 4.1 Subjects an adjuvant setting should have progressed during or within 6 months of completion of adjuvant therapy. 4.2 Subjects who have withdrawn from standard treatment due to unacceptable toxicity warranting discontinuation of treatment and precluding retreatment with the same agent prior to progression of disease will also be allowed into the study. 4.3 Subjects may have received prior treatment with Avastin (bevacizumab)
Subjects must have measurable or non measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria, version 1.1.
Eastern Cooperative Oncology Group (ECOG) Performance Status of 1.
Life expectancy of at least 3 months.
Adequate bone marrow, liver and renal function as assessed by the laboratory required by protocol.
Exclusion Criteria:
Prior treatment with Surufatinib
Previously received anti-programmed death-1 (PD-1) or its ligand (PD-L1) antibody, anti-cytotoxic T lymphocyte-associated antigen 4 (cytotoxic T- lymphocyte-associated Protein 4, CTLA-4) antibody or other drug/antibody that acts on T cell costimulation or checkpoint pathways.
Previous or concurrent cancer that is distinct in primary site or histology from colorectal cancer within 5 years prior to randomization EXCEPT for curatively treated cervical cancer in situ, non-melanoma skin cancer and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor invades lamina propria)].
Cardiological disease including Congestive heart failure, Unstable angina, Myocardial infarction, Cardiac arrhythmias requiring anti-arrhythmic therapy.
Uncontrolled hypertension. (Systolic blood pressure 150 mmHg or diastolic pressure 90 mmHg despite optimal medical management).
Pleural effusion or ascites that causes respiratory compromise. Arterial or venous thrombotic or embolic events.
Any history of or currently known brain metastases.
Interstitial lung disease with ongoing signs and symptoms at the time of informed consent.
Systemic anticancer therapy including cytotoxic therapy, signal transduction inhibitors, immunotherapy, and hormonal therapy during this trial or within 4 week.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yanhong Deng, Ph.D
Phone
86-13925106525
Email
13925106525@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yanhong Deng, Ph.D
Organizational Affiliation
Sixth Affiliated Hospital, Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Sixth Affiliated Hospital of Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510655
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanhong Deng, Ph.D
Phone
86-13925106525
Email
13925106525@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Surufatinib and Sintilimab in Combination With Capecitabine for Metastatic Adenocarcinoma of Small Intestine or Appendix Carcinoma
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