Systemic Chemotherapy, Lenvatinib Plus Sintilimab for ICC With Distant Metastasis

NCT04769908 | Unknown Phase 2 DMC

• 1 other identifier: S-077C
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

ICC

Keywords

ICC; Lenvatinib; Sintilimab; Systemic Chemotheray

Outcome Measures

Primary Outcomes (1)

• Objective response rate per RECIST

  complete response and partial response per RECIST

  6 months

Secondary Outcomes (3)

• Overall survival

  6 months

• Progression-free survival

  6 months

• Number of adverse events

  30 days

Study Arms (1)

Systemic Chemotherapy, Lenvatinib Plus Sintilimab

EXPERIMENTAL

Drug: Systemic Chemotherapy; Drug: Lenvatinib; Drug: Sintilimab

Interventions

Systemic Chemotherapy DRUG

Systemic Chemotherapy (Oxaliplatin#5-fluorouracil and leucovorin)

Systemic Chemotherapy, Lenvatinib Plus Sintilimab

Lenvatinib DRUG

Lenvatinib, 8mg or 12mg, po, QD

Systemic Chemotherapy, Lenvatinib Plus Sintilimab

Sintilimab DRUG

Sintilimab, IV, 200mg, q3w

Systemic Chemotherapy, Lenvatinib Plus Sintilimab

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 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

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

RECRUITING

MeSH Terms

Interventions

Neoadjuvant Therapy; lenvatinib; sintilimab

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics

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: Proffessor

Study Record Dates

• First Submitted: February 22, 2021
• First Posted: February 25, 2021
• Study Start: February 23, 2021
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: February 25, 2021

Record last verified: 2021-02

Locations

CN (1)