HAIC With FOLFOX Versus Systemic Chemotherapy With GP for Unresectable ICC

NCT04961970 | Unknown Phase 3 DMC

• 1 other identifier: S035B
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Intrahepatic Cholangiocarcinoma

Keywords

intrahepatic cholangiocarcinoma; systemic chemotherapy; hepatic artery infusion chemotherapy

Outcome Measures

Primary Outcomes (1)

• Overall survival

  OS was defined as the duration from the date of randomization until the date of death from any cause. Participants who were lost to follow-up were censored at the last date the participant was known to be alive, and participants who remained alive were censored at the time of data cutoff.

  12 months

Secondary Outcomes (3)

• Progression free survival

  12 months

• Time to progression

  12 months

• Number of adverse events.

  30 days

Study Arms (2)

Hepatic artery infusion chemotherapy

EXPERIMENTAL

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

Drug: oxaliplatin , fluorouracil, and leucovorin

Systemic chemotherapy

ACTIVE COMPARATOR

Participants received systemic chemotherapy of gemcitabine and cisplatin

Drug: gemcitabine and cisplatin

Interventions

oxaliplatin , fluorouracil, and leucovorin DRUG

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

Hepatic artery infusion chemotherapy

gemcitabine and cisplatin DRUG

administration of gemcitabine and cisplatin via vein

Systemic chemotherapy

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
• 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

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.
• Known central nervous system tumors including metastatic brain disease

Sponsors & Collaborators

• Shi Ming: lead

Study Sites (1)

Cancer Center Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Cholangiocarcinoma

Interventions

Oxaliplatin; Fluorouracil; Leucovorin; Gemcitabine; Cisplatin

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Proffessor

Study Record Dates

• First Submitted: July 7, 2021
• First Posted: July 14, 2021
• Study Start: July 9, 2021
• Primary Completion: July 9, 2025
• Study Completion: July 9, 2025
• Last Updated: July 14, 2021

Record last verified: 2021-07

Locations

CN (1)