Systemic Chemotherapy, Apatinib Plus Sintilimab for Metastasis ICC

NCT04682249 | Withdrawn Phase 2 DMC

• 1 other identifier: SL077B
• 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(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 metastatic ICC.

Conditions

ICC

Keywords

ICC; Systemic Chemotheray; Apatinib; Sintilimab

Outcome Measures

Primary Outcomes (1)

• Objective response rate

  6 months

Secondary Outcomes (3)

• Overall survival

  6 months

• Progression-free survival

  6 months

• Number of adverse events

  30 days

Study Arms (1)

Systemic Chemotheray, Apatinib plus Sintilimab

EXPERIMENTAL

Drug: Systemic Chemotherapy; Drug: Sintilimab; Drug: Apatinib

Interventions

Systemic Chemotherapy DRUG

Systemic Chemotherapy (Oxaliplatin#5-fluorouracil and leucovorin)

Systemic Chemotheray, Apatinib plus Sintilimab

Sintilimab DRUG

Sintilimab

Systemic Chemotheray, Apatinib plus Sintilimab

Apatinib DRUG

Apatinib

Systemic Chemotheray, Apatinib 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 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

Location

MeSH Terms

Interventions

Neoadjuvant Therapy; sintilimab; apatinib

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: December 20, 2020
• First Posted: December 23, 2020
• Study Start: December 1, 2020
• Primary Completion: February 1, 2021
• Study Completion: February 1, 2021
• Last Updated: February 4, 2021

Record last verified: 2021-02

Locations

CN (1)