HAIC Versus Systemic Chemotherapy for Unresectable ICC

NCT ID: NCT03771846

Last Updated: 2019-12-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 188 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-01
• Study Completion Date: 2022-08-01

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of hepatic arterial infusion chemotherapy (HAIC) of irinotecan, oxaliplatin, 5-fluorouracil and leucovorin compared systemic chemotherapy of gemcitabine and oxaliplatin in patients with unresectable intrahepatic cholangiocarcinoma.

Conditions

Intrahepatic Cholangiocarcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hepatic artery infusion chemotherapy

Participants received hepatic artery infusion chemotherapy of irinotecan, oxaliplatin, 5-fluorouracil and leucovorin

Group Type: EXPERIMENTAL

irinotecan, oxaliplatin , fluorouracil, and leucovorin

Intervention Type: DRUG

administration of irinotecan, oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries

Systemic chemotherapy

Participants received systemic chemotherapy of gemcitabine and oxaliplatin

Group Type: ACTIVE_COMPARATOR

gemcitabine and oxaliplatin

Intervention Type: DRUG

administration of gemcitabine and oxaliplatin via vein

Interventions

irinotecan, oxaliplatin , fluorouracil, and leucovorin

administration of irinotecan, oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries

Intervention Type: DRUG

gemcitabine and oxaliplatin

administration of gemcitabine and oxaliplatin via vein

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• The diagnosis of ICC
• 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.
• Without distant metastasis, but intrahepatic lymph node metastasis is allowed
• 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

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.
• Known central nervous system tumors including metastatic brain disease

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shi Ming

OTHER

Sponsor Role: lead

Responsible Party

Shi Ming

Proffessor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ming Shi, MD

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

Cancer Center Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Ming Shi

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Ming Shi, MD

Role: CONTACT

shiming@sysucc.org.cn

(8620)-87343938

Facility Contacts

Ming Shi, MD

Role: primary

shiming@mail.sysu.edu.cn

8620-87343115

Ming Shi, MD

Role: primary

shiming@sysucc.org.cn

(8620)-87343938

Other Identifiers

S035

Identifier Type: -

Identifier Source: org_study_id