Back to resultsSystemic Chemotherapy Plus PD-1 for Metastasis ICC
Primary Purpose
ICC, Metastatic Cancer
Status
Withdrawn
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Folfirinox
Sintilimab
Sponsored by
About this trial
This is an interventional treatment trial for ICC focused on measuring ICC, metastasis
Eligibility Criteria
Inclusion Criteria:
- The diagnosis of ICC
- With distant metastasis
- Patients must have at least one tumor lesion that can be accurately measured according to mRECIST criteria.
- With no previous treatment
- No Cirrhosis or cirrhotic status of Child-Pugh class A only
- Not amendable to surgical resection ,local ablative therapy and any other cured treatment
- The following laboratory parameters:
Platelet count ≥ 50,000/μL Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 30mmol/ L Serum albumin ≥ 32 g/L ASL and AST ≤ 6 x upper limit of normal Serum creatinine ≤ 1.5 x upper limit of normal INR ≤ 1.5 or PT/APTT within normal limits Absolute neutrophil count (ANC) >1,500/mm3
Exclusion Criteria:
- Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
- Known history of HIV
- History of organ allograft
- Known or suspected allergy to the investigational agents or any agent given in association with this trial.
- Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
- Evidence of bleeding diathesis.
- Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
Sites / Locations
- Cancer Center Sun Yat-sen University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Folfirinox plus PD1
Arm Description
Patients treated with systemic chemotherapy(regimen: Folfirinox) plus PD1
Outcomes
Primary Outcome Measures
Progression free survival rate of 6 months
Ratio of patients observed progression of tumor at 6 months
Secondary Outcome Measures
Overall survival
Time from enrollment to death for any reason.
Number of adverse events
Postoperative adverse events were graded based on CTCAE v4.03
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04398927
Brief Title
Systemic Chemotherapy Plus PD-1 for Metastasis ICC
Official Title
Systemic Chemotherapy Based on Oxaliplatin and 5-fluorouracil Plus PD-1 for Metastasis ICC-single Arm Prospective Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Withdrawn
Why Stopped
no patient enrolled
Study Start Date
May 1, 2020 (Actual)
Primary Completion Date
January 1, 2021 (Actual)
Study Completion Date
February 1, 2021 (Actual)
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
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study were designed to verify the better method of survival for metastatic ICC.
Since the traditional method for metastatic ICC was GEMOX(recommended from NCCN guideline), our previous study found better results from Folfirinox over GEMOX.
Our current study were conducted for further investigation to verify the better method for metastatic ICC.
Detailed Description
ICC(Intrahepatic CholangioCarcinoma) patients with metastasis has a short survival time and poor prognosis after diagnosis. Treatment methods was few and far from satisfaction. The treatment recommended from NCCN guideline was GEMOX(Systemic Chemotheray) and clinical trials. Our previous study has demonstrate Folfirinox(Systemic Chemotheray based on Oxaliplatin，5-fluorouracil and Irinotecan) has a survival and tumor response advantage of GEMOX.
Further study was needed to intensive confirmation of the result. We designed this study to demonstrate the hypothesis. Metastasis ICCs were recruited and screened by our criteria. All patients were treated with Folfirinox(Systemic Chemotheray based on Oxaliplatin，5-fluorouracil and Irinotecan) plus PD1(Sintilimab).
The progression free survival and overall survival were our primary and secondary endpoint.
Our study were designed to verify the better method of survival for metastatic ICC.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ICC, Metastatic Cancer
Keywords
ICC, metastasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Folfirinox plus PD1
Arm Type
Experimental
Arm Description
Patients treated with systemic chemotherapy(regimen: Folfirinox) plus PD1
Intervention Type
Drug
Intervention Name(s)
Folfirinox
Intervention Description
Systemic Chemotherapy (Oxaliplatin，5-fluorouracil and Irinotecan)
Intervention Type
Drug
Intervention Name(s)
Sintilimab
Intervention Description
Sintilimab
Primary Outcome Measure Information:
Title
Progression free survival rate of 6 months
Description
Ratio of patients observed progression of tumor at 6 months
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Overall survival
Description
Time from enrollment to death for any reason.
Time Frame
6 months
Title
Number of adverse events
Description
Postoperative adverse events were graded based on CTCAE v4.03
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The diagnosis of ICC
With distant metastasis
Patients must have at least one tumor lesion that can be accurately measured according to mRECIST criteria.
With no previous treatment
No Cirrhosis or cirrhotic status of Child-Pugh class A only
Not amendable to surgical resection ,local ablative therapy and any other cured treatment
The following laboratory parameters:
Platelet count ≥ 50,000/μL Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 30mmol/ L Serum albumin ≥ 32 g/L ASL and AST ≤ 6 x upper limit of normal Serum creatinine ≤ 1.5 x upper limit of normal INR ≤ 1.5 or PT/APTT within normal limits Absolute neutrophil count (ANC) >1,500/mm3
Exclusion Criteria:
Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
Known history of HIV
History of organ allograft
Known or suspected allergy to the investigational agents or any agent given in association with this trial.
Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
Evidence of bleeding diathesis.
Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ming Shi
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Center Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
12. IPD Sharing Statement
Learn more about this trial
Systemic Chemotherapy Plus PD-1 for Metastasis ICC
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