Systemic Chemotherapy, Lenvatinib Plus Sintilimab for ICC With Distant Metastasis

NCT ID: NCT04769908

Last Updated: 2021-02-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-23
• Study Completion Date: 2021-12-01

Brief Summary

This study were designed to verify the better method of survival for ICC with distant metastasis. Since the traditional method for ICC with distant metastasis. was GEMOX(first-line treatment from NCCN guideline), our previous study found similar results from FOLFOX (second-line treatment from NCCN guideline) compared with GEMOX.

Our current study were conducted for further investigation to verify the better method for with distant metastasis.

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 FOLFOX (Systemic Chemotheray based on Oxaliplatin#5- fluorouracil) has a similar survival and tumor response compared with 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 FOLFOX (Systemic Chemotheray based on Oxaliplatin#5-fluorouracil ), lenvatinib (one of tyrosine kinase inhibitors) plus sintilimab (one of PD-1 antibody).

Conditions

ICC

Study Design

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

Study Groups

Systemic Chemotherapy, Lenvatinib Plus Sintilimab

Group Type: EXPERIMENTAL

Systemic Chemotherapy

Intervention Type: DRUG

Systemic Chemotherapy (Oxaliplatin#5-fluorouracil and leucovorin)

Lenvatinib

Intervention Type: DRUG

Lenvatinib, 8mg or 12mg, po, QD

Sintilimab

Intervention Type: DRUG

Sintilimab, IV, 200mg, q3w

Interventions

Systemic Chemotherapy

Systemic Chemotherapy (Oxaliplatin#5-fluorouracil and leucovorin)

Intervention Type: DRUG

Lenvatinib

Lenvatinib, 8mg or 12mg, po, QD

Intervention Type: DRUG

Sintilimab

Sintilimab, IV, 200mg, q3w

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• The diagnosis of Intrahepatic CholangioCarcinoma (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 ≥ 60,000/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

Proffessor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cancer Center Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Ming Shi, MD

Role: primary

shiming@mail.sysu.edu.cn

8620-87343115

Other Identifiers

S-077C

Identifier Type: -

Identifier Source: org_study_id