Cetuximab Plus Irinotecan in Patients With NeoRAS Wild-type Metastatic Colorectal Cancer In Third-line Therapy

NCT05962502 | Recruiting Phase 2

• 1 other identifier: NEORAS-SYSUCC
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-arm, open-label, phase II clinical trial. The goal of this study is to evaluate the efficacy and safety of cetuximab plus irinotecan in patients with NeoRAS wild-type primary left-sided mCRC in third-line therapy.

Conditions

Metastatic Colorectal Cancer

Keywords

NeoRAS wild-type; mCRC; Cetuximab; Third-line therapy

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  Based on RECIST 1.1

  Up to 1 year

Secondary Outcomes (3)

• Progression free survival (PFS)

  Up to 2 years

• Overall survival (OS)

  Up to 3 years

• Drug-related adverse reactions

  Up to 3 years

Study Arms (1)

cetuximab plus irinotecan

EXPERIMENTAL

Cetuximab 500 mg/m2 iv drip 90 min d1, Irinotecan 180 mg/m2 iv drip d1 (For patients with UGT\*28 7/7 or UGT\*6 A/A or UGT\*28 6/7 plus UGT\*6 A/G, irinotecan 150 mg/m2 is used) The above regimen is repeated every 2 weeks

Drug: Cetuximab and irinotecan

Interventions

Cetuximab and irinotecan DRUG

chemotherapy plus targeted therapy

Also known as: ERBITUX

cetuximab plus irinotecan

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years.
• Histologically confirmed colorectal adenocarcinoma.
• Patients with initial RAS mutant, BRAF wild-type left-sided mCRC.
• Progression after standard first-line and second-line therapy (previously treated with fluorouracil compounds, oxaliplatin and irinotecan).
• Tumor progression within 3 months during or after irinotecan-containing regimen.
• Blood-based ctDNA testing shows that both RAS and BRAF genes are wild-type after second-line therapy progression .
• There are objectively measurable lesions according to RECIST v1.1 criteria.
• Normal hematologic function (platelets \> 90 × 109/L; leukocytes \> 3 × 109/L; neutrophils \> 1.5 × 109/L; hemoglobin \> 8.0g/100ml).
• Serum bilirubin ≤ 1.5 x the upper limit of normal (ULN) and transaminases ≤ 5 x ULN.
• Normal coagulation function, albumin ≥ 35 g/L.
• Liver function: Child-Push score: Class A.
• Serum creatinine \< 1.5 x ULN, or calculated creatinine clearance ≥ 50 ml/min (using the Cockcroft Gault formula).
• ECOG PS score 0-2.
• Life expectancy \> 3 months.
• Sign written informed consent.

You may not qualify if:

• Primary right-sided mCRC.
• dMMR/MSI-H mCRC.
• Patients with initial RAS wild-type or BRAF mutant mCRC.
• ctDNA testing shows that RAS or BRAF gene is mutant mCRC after second-line therapy.
• Serious arterial embolism or ascites.
• Serious bleeding tendency or coagulation disorder.
• Serious uncontrolled systemic complications such as infection or diabetes.
• Clinically significant cardiovascular disease such as cerebrovascular accident (within 6 months prior to enrollment), myocardial infarction (within 6 months prior to enrollment), uncontrolled hypertension despite appropriate medical treatment. Unstable angina, congestive heart failure (NYHA class 2-4), cardiac arrhythmia requiring medication.
• History or physical evidence of central nervous system disease (e.g., primary brain tumor, epilepsy uncontrolled by standard of care, any history of brain metastases or stroke).
• Other malignancies (except cutaneous basal cell carcinoma and/or cervical carcinoma in situ of the cervix and/or thyroid carcinoma after radical surgery) within the past 5 years.
• Hypersensitivity to any drug in the study.
• Pregnant and lactating women.
• Women of childbearing age (\< 2 years after last menstruation) or men of fertile potential who are not using or refuse to use effective non-hormonal contraception (intrauterine contraceptive ring, barrier contraceptives combined with spermicidal gel, or surgical sterilization).
• Unable or unwilling to comply with the study protocol.
• Patients with any other diseases, dysfunction caused by metastatic lesions, or suspected disease found by physical examination, indicating possible contraindications to the use of the investigational drug or putting the patients at high risk of treatment-related complications.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Cancer center of Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Cetuximab; Irinotecan

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; Camptothecin; Alkaloids; Heterocyclic Compounds

Study Officials

• Ruihua Xu, MD, PhD

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ruihua Xu, MD, PhD

CONTACT

+86 13922206676; xurh@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 17, 2023
• First Posted: July 27, 2023
• Study Start: August 24, 2023
• Primary Completion: March 30, 2025
• Study Completion (Estimated): December 30, 2026
• Last Updated: August 31, 2023

Record last verified: 2023-08

Locations

CN (1)