Loading clinical trials...

UNKNOWNPHASE2

Preoperative Systemic Therapy for Colorectal Cancer Peritoneal Metastases

Preoperative Systemic Therapy With FOLFOXIRI Plus Bevacizumab Followed by Cytoreductive Surgery Versus Upfront Cytoreductive Surgery for Resectable Colorectal Peritoneal Metastases: A Randomized Phase 2 Trial

NCT05353582•Sun Yat-sen University

View on ClinicalTrials.gov

Summary

This is an open-label, parallel-group, phase 2 randomized trial which randomizes patients with isolated resectable colorectal cancer peritoneal metastases to receive preoperative systematic therapy followed by CRS+HIPEC and postoperative chemotherapy or upfront CRS+HIPEC followed by postoperative chemotherapy.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
•Historically and radiologically confirmed colorectal cancer peritoneal metastasis except for appendical origin;
•Tolerable to scheduled chemotherapy;
•No evidence of extraperitoneal metastases at enrollment;
•Resectable disease determined by radiological and laparoscopy/laparotomy;
•No systematic therapy within 6 months before enrollment;
•Tolerable to cytoreductive surgery.

Exclusion Criteria

•Without adequate organ function (e.g. :neutrophil countt≤1.5×10\^9/L, or platelets≤75×10\^12/L，or hemoglobin\<90g/L, or aminotransferase、aspartate aminotransferaseAST\<2.5ULN, or total bilirubin\<1.5ULN, or creatinine\<1.5ULN;
•Emergency surgery;
•Recent thromboembolic event or cerebrovascular disease (12 months before enrollment);
•Pregnancy or lactation
•Comorbid with severe physical or mental disease.

Locations (1)

Sixth Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Key Dates

Start Date

June 1, 2022

Primary Completion Date

July 1, 2025

Completion Date

July 1, 2025

Last Updated

April 29, 2022

Enrollment

168

ESTIMATED participants

Conditions

Colorectal NeoplasmsColorectal CancerColorectal Cancer MetastaticPeritoneal MetastasesPeritoneal CancerPeritoneal NeoplasmsChemotherapy EffectCytoreductive SurgeryHyperthermic Intraperitoneal Chemotherapy

Interventions

Preoperative systematic therapy

DRUG

CRS+HIPEC

PROCEDURE

Postoperative chemotherapy

DRUG

Postoperative chemotherapy

DRUG

Contacts

Hui Wang, MD

CONTACT

+86-13926424886 wang89@mail.sysu.edu.cn

Huaiming Wang

CONTACT

wanghm@mail.ssysu.edu.cn

Clinical Trial of an Anti-cancer Drug, CA-4948 (Emavusertib), in Combination With Chemotherapy Treatment (FOLFOX Plus Bevacizumab) in Metastatic Colorectal Cancer

NCT06696768

Metastatic Colorectal AdenocarcinomaStage III Colorectal Cancer AJCC v8+2 more

View study

RECRUITINGPHASE1

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

NCT04704661

Advanced Breast CarcinomaAdvanced Colon Carcinoma+38 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 29, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Preoperative Systemic Therapy for Colorectal Cancer Peritoneal Metastases

Inclusion Criteria

Exclusion Criteria

Clinical Trial of an Anti-cancer Drug, CA-4948 (Emavusertib), in Combination With Chemotherapy Treatment (FOLFOX Plus Bevacizumab) in Metastatic Colorectal Cancer

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

A Study of Amivantamab and mFOLFOX6 or FOLFIRI Versus Cetuximab and mFOLFOX6 or FOLFIRI as First-line Treatment in Participants With KRAS/NRAS and BRAF Wild-type Unresectable or Metastatic Left-sided Colorectal Cancer

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors

A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors