FOLFOX Via HAI Plus Intravenous Irinotecan With or Without Bevacizumab Versus Systemic FOLFOXIRI With or Without Bevacizumab in Initially Unresectable RAS-mutated CRLM Patients

Colorectal Cancer Metastatic Clinical Trial

Official title:
FOLFOX Via Hepatic Artery Infusion Chemotherapy (HAI) Plus Systemic Irinotecan With or Without Bevacizumab Versus Systemic FOLFOXIRI With or Without Bevacizumab in Patients With Initially Unresectable RAS-mutated Colorectal Cancer With Liver Metastases: A Prospective, Randomized, Controlled Clinical Study

Status Recruiting

Clinical Trial Summary

This prospective, randomized, controlled clinical study aims to evaluate the objective remission rate of FOLFOX hepatic artery infusion chemotherapy (HAI) in combination with systemic irinotecan with or without bevacizumab versus systemic intravenous FOLFOXIRI with or without bevacizumab in initially unresectable RAS-mutated colorectal cancer patients with liver metastases.

Clinical Trial Description

PRIMARY OBJECTIVES: The goal of this prospective, randomized, controlled clinical trial is to evaluate the objective remission rate (ORR) of FOLFOX hepatic artery infusion chemotherapy (HAI) in combination with irinotecan with or without bevacizumab systemic intravenous chemotherapy versus systemic intravenous FOLFOXIRI with or without bevacizumab in initially unresectable RAS-mutated colorectal cancer patients with liver metastases. SECONDARY OBJECTIVES: To assess and compare the depth of response (DpR), R0 surgical resection rate, No evidence of disease (NED) rate, progression-free survival (PFS), overall survival (OS), recurrence-free survival (RFS) in resectable patients and safety (chemotherapy-related adverse events, catheterization-related adverse events, surgical complications, etc.) between the two intervention groups. OUTLINE: Patients in the HAI group receive FOLFOX via hepatic artery infusion chemotherapy plus intravenous irinotecan with or without bevacizumab every 14 days, while patients in the systemic group receive intravenous FOLFOXIRI regimen with or without bevacizumab every 14 days. Patients will receive a maximum of 12 cycles in total (before and after surgery) unless there is disease progression, unacceptable toxicity, or if the patient withdraws from the study. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05727163
Study type	Interventional
Source	Sun Yat-sen University
Contact	Li Yuhong
Phone	020-87342487
Email	liyh@sysucc.org.cn
Status	Recruiting
Phase	Phase 2
Start date	July 29, 2022
Completion date	December 31, 2026

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT03941080` - Gut Microbiome Dynamics in Metastasized or Irresectable Colorectal Cancer
Completed	`NCT03213314` - HepaT1ca: Quantifying Liver Health in Surgical Candidates for Liver Malignancies	N/A
Completed	`NCT03647839` - Modulation Of The Tumour Microenvironment Using Either Vascular Disrupting Agents or STAT3 Inhibition in Order to Synergise With PD1 Inhibition in Microsatellite Stable, Refractory Colorectal Cancer	Phase 2
Recruiting	`NCT05057052` - Cryoablation Combined With Sintilimab Plus Regorafenib In Previously Treated Colorectal Cancer Liver Metastasis	Phase 2
Terminated	`NCT02316496` - Rechallenge of Cetuximab Combined With Irinotecan as Third-line Chemotherapy in Patients With Metastatic Colorectal Cancer - Phase II Study	Phase 2
Completed	`NCT03251612` - Predictive Value of Drug Sensitivity Testing Tumorspheres From Patients With Metastatic Colorectal Cancer	Phase 2
Completed	`NCT02380443` - AlloStim® Immunotherapy Dosing Alone or in Combination With Cryoablation in Metastatic Colorectal Cancer	Phase 2
Recruiting	`NCT02149784` - Effectiveness Study of Resection of Primary Tumor in Stage IV Colorectal Cancer Patients	Phase 3
Recruiting	`NCT01959061` - Efficacy and Safety of Raltitrexed-based Transarterial Chemoembolisation(TACE)for Colorectal Cancer Liver Metastases	Phase 4
Terminated	`NCT01668680` - Maintenance Metronomic Chemotherapy for Metastatic Colorectal Carcinoma	Phase 2
Recruiting	`NCT05068531` - Early Detection of Treatment Failure in Metastatic Colorectal Cancer Patients
Not yet recruiting	`NCT04525807` - Precision Medicine for Colorectal Cancer Liver Metastasis Guided by Multi-omics Data Under the Umbrella Theory
Completed	`NCT04482608` - The mCRC Patients With pMMR/MSS or dMMR/MSI-H Status Received Palliative Chemotherapy Efficacy and Survival
Recruiting	`NCT03193710` - The Effects of General Anesthetics on Lymphocytes in Patients Undergoing Colorectal Cancer Resection and Mechanism Involved	N/A
Recruiting	`NCT04854213` - PRELUDE-1 (Prospective Evaluation of Radiotherapy-induced Biologic Effects in Colorectal Cancer Oligometastatic Patients With LUng-limited Disease: Evolution of Cancer Genetics and Regulatory Immune Cells)	N/A
Suspended	`NCT04108481` - Immunotherapy With Y90-RadioEmbolization for Metastatic Colorectal Cancer	Phase 1/Phase 2
Completed	`NCT03142516` - FOLFIRI + Panitumumab First-line Treatment in Elderly Patients With Unresectable Metastatic Colorectal Cancer, RAS/BRAF Wild-type and Good Performance Status	Phase 2
Completed	`NCT03144804` - A Phase 2 Study of Lamivudine in Patients With p53 Mutant Metastatic Colorectal Cancer	Phase 2
Active, not recruiting	`NCT01910610` - Multi-Line Therapy Trial in Unresectable Metastatic Colorectal Cancer	Phase 3
Recruiting	`NCT05759728` - A Study of CNA3103 (LGR5-targeted, Autologous CAR-T Cells) Administered to Subjects With Metastatic Colorectal Cancer	Phase 1/Phase 2