Overview

Systemic Chemotherapy, Lenvatinib Plus Sintilimab for ICC With Distant Metastasis

Status:
Recruiting
Trial end date:
2021-12-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Sun Yat-sen University
Treatments:
Lenvatinib
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.