Cetuximab Re-challenge for Colorectal Cancer Liver Metastasis

NCT04509635 | Unknown Phase 3 DMC

• 1 other identifier: Cet-rechallenge
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

For patients with unresectable colorectal cancer liver metastases, preclinical studies have shown that after the resistance of cetuximab, the treatment sensitivity can be restored by stopping cetuximab for a period of time. This is called the cetuximab re-challenge. And the circulating tumor DNA (ctDNA) test is reported a biomarker for the efficacy of cetuximab rechallenge. However, there is still no randomized controlled trial for verification. This study aims at patients after the first-line treatment of cetuximab has progressed. After the second-line non-cetuximab treatment has progressed, the effects of re-application of combined with cetuximab and chemotherapy alone are compared to verify the re-challenge effect.

Conditions

Colorectal Cancer; Liver Metastases; Cetuximab

Keywords

Colorectal Cancer; Liver Metastases; Cetuximab; Re-challenge

Outcome Measures

Primary Outcomes (1)

• disease control rate

  According to the RECIST v.1.1, the disease control rate (DCR) is the proportion of patients with complete response (CR), partial response (PR) and stable disease (SD), evaluated by radiology (CT, MRI, etc.).

  2 years

Secondary Outcomes (3)

• objective response rate

  2 years

• progression-free survival

  2 years

• overall survival

  2 years

Study Arms (2)

Arm A

EXPERIMENTAL

Using treatment of cetuximab plus chemotherapy. Cetuximab: 500 mg/m2 IV over 2 hours, day 1, every 2 weeks. Chemotherapy: detailed regimen is determined by a multi-disciplinary team.

Drug: Cetuximab; Drug: Chemotherapy

Arm B

ACTIVE COMPARATOR

Using treatment of chemotherapy alone. Chemotherapy: detailed regimen is determined by a multi-disciplinary team

Drug: Chemotherapy

Interventions

Cetuximab DRUG

Cetuximab is used for only patients with ctDNA test RAS wild type.

Arm A

Chemotherapy DRUG

The detailed regimen is determined by a multi-disciplinary team according to the previous use of chemotherapy.

Arm A; Arm B

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary tumour was histologically confirmed colorectal adenocarcinoma;
• Clinical or radiological evidence of non-resectable liver metastases;
• With at least one measurable tumor;
• Received first-line cetuximab (RAS gene wild type) treatment and progressed
• Received second-line non-cetuximab treatment and progressed
• Received circulating tumor DNA test and has RAS gene wild type status;
• Performance status (ECOG) 0\~1
• A life expectancy of ≥ 3 months
• Adequate hematological function: Neutrophils≥1.5 x109/l and platelet count≥100 x109/l; Hb ≥9g/dl (within 1 week prior to randomization)
• Adequate hepatic and renal function: Serum bilirubin≤1.5 x upper limit of normal (ULN), alkaline phosphatase ≤5x ULN, and serum transaminase (either aspartate transaminase (AST) or alanine transaminase (ALT)) ≤ 5 x ULN(within 1 week prior to randomization);
• Written informed consent for participation in the trial.

You may not qualify if:

• Patients with known hypersensitivity reactions to any of the components of the study treatments.
• Acute or sub-acute intestinal occlusion
• Pregnancy (absence confirmed by serum/urine β-HCG) or breast-feeding
• Other previous malignancy within 5 years, with exception of a history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix Known drug abuse/ alcohol abuse
• Legal incapacity or limited legal capacity
• Pre-existing peripheral neuropathy.

Sponsors & Collaborators

• Fudan University: lead

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Cetuximab; Drug Therapy

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Therapeutics

Central Study Contacts

Jianmin Xu, Prof.

CONTACT

86-13501984869; xujmin@aliyun.com

Qingyang Feng, Dr.

CONTACT

fqy198921@163.com

Study Design

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

Study Record Dates

• First Submitted: August 10, 2020
• First Posted: August 12, 2020
• Study Start: September 1, 2020
• Primary Completion: August 31, 2022
• Study Completion: August 31, 2024
• Last Updated: August 12, 2020

Record last verified: 2020-08