Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Antineoplastic Agents

All Drugs and Chemicals

Capecitabine

Cetuximab

Antimetabolites

Antineoplastic Agents, Immunological

Maintenance therapy with Cetuximab as intravenous (IV) infusion at the dose of 500 mg/m2, given every 2 weeks (Q2W); plus capecitabine in 2-week cycles until progressive disease, death from any cause, unacceptable toxicity or informed consent withdrawal

Maintenance therapy with Cetuximab as intravenous (IV) infusion at the dose of 500 mg/m2, given every 2 weeks (Q2W) until progressive disease, death from any cause, unacceptable toxicity or informed consent withdrawal

Cetuximab, Capecitabine

Ruihua Xu, MD

This is an open-label, multicenter, randomized study to be conducted in Chinese patients with RAS and BRAF wild-type mCRC. Patients who have already completed 9 cycles of standard first-line induction treatment, without discontinuation for toxicity, of cetuximab or fluorouracil or oxaliplatin,, and achieved disease control (including CR/PR and SD), and are progression free at the end of Cycle 9 will be assigned to 2 maintenance treatment groups by randomization in a 1:1 ratio to receive cetuximab + capecitabine (Arm A) or cetuximab alone (Arm B). The randomization will be stratified by induction treatment response (complete response \[CR\]+ partial response \[PR\] versus stable disease \[SD\]) and primary tumor location (left side only versus right side). All patients from Arm A and Arm B will be treated until progressive disease, death from any cause, unacceptable toxicity or informed consent withdrawal (whichever occurs earlier).

Coz COVID-19 limited, C-CLASSIC was terminated recruitment on 31Dec2022. Total screen 100 subjects and enroll 80 subjects. All subjects in study will be treatment until meet study endpoint. Then study related subject follow up, data collect, clinical study report will be continued as planned.

Cetuximab Plus Capecitabine as Maintenance Treatment in RAS and BRAF wt Metastatic Colorectal Cancer

A Phase III, Multicenter, Open-label, Randomized Study to Assess the Efficacy and Safety of Cetuximab Plus Capecitabine Versus Cetuximab as Maintenance Treatment Following First-line Induction Treatment With FOLFOX and Cetuximab in Chinese Patients With RAS and BRAF Wild-type Metastatic Colorectal Cancer

Mutation status of selected genes (include but are not limited to KRAS, NRAS, BRAF, HER2, PI3K, NTRK, POLE, etc ) is assessed using Next-Generation Sequencing Method. It will be evaluated at Screening and End of Treatment visit with peripheral blood samples.

mPFS from randomization to PD or death from any cause

AEs included SAEs and non-serious AEs. Causality to study treatment was determined by the investigator. Severity was graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

Clinical laboratory tests include hematology, electrolyte and clinical chemistry.

Quality of life is assessed using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30. It will be evaluated at Screening, Tumor Assessment Visit and End of Treatment visit.

Quality of life in patients with colorectal cancer is assessed using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) CR29. It will be evaluated at Screening, Tumor Assessment Visit and End of Treatment visit.

Time from randomization to death from any cause

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Cetuximab Plus Capecitabine as Maintenance Treatment in RAS and BRAF wt Metastatic Colorectal Cancer	NCT04262635	Colorectal Canc...	Cetuximab, Cape... Cetuximab	18 Years -	Sun Yat-sen University
Cetuximab Plus Capecitabine as Maintenance Treatment in RAS and BRAF wt Metastatic Colorectal Cancer	NCT04262635	Colorectal Canc...	Cetuximab, Cape... Cetuximab	18 Years -	Sun Yat-sen University

Spots Global Cancer Trial Database for cetuximab, capecitabine