Systemic Chemotherapy Plus PD-1 for Metastasis ICC

Sun Yat-sen University

Status and phase

Withdrawn

Phase 2

Conditions

Metastatic Cancer

ICC

Treatments

Drug: Folfirinox

Drug: Sintilimab

Study type

Interventional

Funder types

Other

Identifiers

NCT04398927

S077

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.