Systemic Chemotherapy Plus PD-1 for Metastasis ICC

NCT04398927 | Withdrawn Phase 2 DMC

• 1 other identifier: S077
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

ICC; Metastatic Cancer

Keywords

ICC; metastasis

Outcome Measures

Primary Outcomes (1)

• Progression free survival rate of 6 months

  Ratio of patients observed progression of tumor at 6 months

  6 months

Secondary Outcomes (2)

• Overall survival

  6 months

• Number of adverse events

  30 days

Study Arms (1)

Folfirinox plus PD1

EXPERIMENTAL

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

Drug: Folfirinox; Drug: Sintilimab

Interventions

Folfirinox DRUG

Systemic Chemotherapy (Oxaliplatin，5-fluorouracil and Irinotecan)

Folfirinox plus PD1

Sintilimab DRUG

Sintilimab

Folfirinox plus PD1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Cancer Center Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

folfirinox; sintilimab

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ming Shi

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 19, 2020
• First Posted: May 22, 2020
• Study Start: May 1, 2020
• Primary Completion: January 1, 2021
• Study Completion: February 1, 2021
• Last Updated: February 4, 2021

Record last verified: 2020-05

Locations

CN (1)