Systemic Chemotherapy Plus PD-1 for Metastasis ICC

NCT ID: NCT04398927

Last Updated: 2021-02-04

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-01
• Study Completion Date: 2021-02-01

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.

Conditions

ICC; Metastatic Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Folfirinox plus PD1

Patients treated with systemic chemotherapy(regimen: Folfirinox) plus PD1

Group Type: EXPERIMENTAL

Folfirinox

Intervention Type: DRUG

Systemic Chemotherapy (Oxaliplatin，5-fluorouracil and Irinotecan)

Sintilimab

Intervention Type: DRUG

Sintilimab

Interventions

Folfirinox

Systemic Chemotherapy (Oxaliplatin，5-fluorouracil and Irinotecan)

Intervention Type: DRUG

Sintilimab

Sintilimab

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Shi Ming

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ming Shi

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

Cancer Center Sun Yat-sen University

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

S077

Identifier Type: -

Identifier Source: org_study_id