Systemic Chemotherapy Plus PD-1 for Metastasis ICC

Phase 2

Withdrawn

• Conditions: ICC; Metastatic Cancer
• Interventions: Drug: Folfirinox; Drug: Sintilimab

• Registration Number: NCT04398927
• Lead Sponsor: Sun Yat-sen University

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.

Study Timeline

• Status Verified: 2020-05
• Study Start: 2020-05-01
• Study First Submitted: 2020-05-19
• Study First Submitted QC: 2020-05-19
• Study First Posted: 2020-05-22
• Primary Completion: 2021-01-01
• Study Completion: 2021-02-01
• Last Update Submitted: 2021-02-01
• Last Update Posted: 2021-02-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Folfirinox plus PD1	Folfirinox	Patients treated with systemic chemotherapy(regimen: Folfirinox) plus PD1
Folfirinox plus PD1	Sintilimab	Patients treated with systemic chemotherapy(regimen: Folfirinox) plus PD1

Primary Outcome Measures

Name	Time	Method
Progression free survival rate of 6 months	6 months	Ratio of patients observed progression of tumor at 6 months

Secondary Outcome Measures

Name	Time	Method
Overall survival	6 months	Time from enrollment to death for any reason.
Number of adverse events	30 days	Postoperative adverse events were graded based on CTCAE v4.03

Trial Locations

Locations (1)

Cancer Center Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China