Chemotherapy With Cetuximab as Conversion Therapy in RAS/BRAF WT Unresectable Liver Metastasis Right-sided Colon Cancer

NCT06322147 | Recruiting

• 1 other identifier: KYLL-202304-31
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study was designed as multi-center, ambispective observational trial to evaluate the efficacy and safety of addition of cetuximab to doublet or triplet chemotherapy as conversion therapy in right-sided BRAF/RAS wild-type CRLM with curative intent. The primary endpoint was radical resection rate (R0). The secondary endpoint was response rate, rate of NED, depth of remission, early tumor shrinkage, progression free survival and safety.

Conditions

Colon Cancer

Outcome Measures

Primary Outcomes (1)

• R0 resection rate

  R0 resection rate upon conversion treatment with chemotherapy plus cetuximab

  1 year

Secondary Outcomes (6)

• Objective response rate

  1 year

• Reported adverse events

  1 year

• Progression free survival

  2 year

• no evidence of disease

  1 year

• depth of response

  1 year

Study Arms (1)

Doublet or triplet chemotherapy combined with cetuximab

Drug: Doublet or triplet chemotherapy combined with cetuximab

Interventions

Doublet or triplet chemotherapy combined with cetuximab DRUG

chemotherapy+cetuximab combination therapy，chemotherapy regimens include FOLFOX, FOLFIRI, XELOX, or mFOLFOXIRI. Cetuximab first dose 400 mg/m2, followed by cetuximab 250 mg/m2 every 2 weeks; mFOLFOX6: oxaliplatin 85 mg/m2 (day 1), 5-FU 400 mg/m2 (day 1), LV 400 mg/m2 (day 1), and 5-FU 2400 mg/m2 CIV (46 h) for up to 12 cycles; XELOX (biweekly): oxaliplatin 85 mg/m2 (day 1), capecitabine 1000 mg/m2, bid, d1-10; FOLFIRI: irinotecan 180 mg/m2 (day 1), 5-FU 400 mg/m2 (day 1), LV 400 mg/m2 (day 1), and 5-FU 2400 mg/m2 CIV (46 h), Up to 12 cycles; mFOLFOXIRI: oxaliplatin 85 mg/m2 (day 1), irinotecan 150 mg/m2 (day 1), 5-FU 400 mg/m2 (day 1), LV 400 mg/m2 (day 1) and 5-FU 2400 mg/m2 CIV (46 h).

Doublet or triplet chemotherapy combined with cetuximab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

RAS/BRAF wild type unresectable liver metastasis right-sided colon cancer

You may qualify if:

• Signed informed consent obtained before any study specific procedures. Subjects must be able to understand and willing to sign a written informed consent;
• Male or female subjects \> 18 years \< 75 of age;
• Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 ;
• Life expectancy of more than 3 months;
• Patients with pathologically confirmed metastatic colorectal liver metastases with molecular testing RAS/BRAF wild-type, MSS;
• At least one measurable lesion in liver metastases according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1;
• No previous any systemic anticancer therapy; if received primary tumor surgery and postoperative adjuvant chemotherapy, more than 6 months from the end of the last chemotherapy;
• Liver metastases are initially unresectable, but can have the opportunity to achieve complete resection or NED status with conversion therapy;
• Patients have adequate bone marrow, hepatic and renal function;

You may not qualify if:

• Any evidence of extra-hepatic metastases, lymph node (including portal lymph nodes) metastases and primary tumor recurrence.
• The primary tumor cannot be completely resected;
• If the possibility of R0 transformation is achieved, the patient refuses surgery due to non-medical factors.

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

Study Sites (1)

Qilu hospital of Shandong University

Jinan, Shandong, 250012, China

RECRUITING

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Cetuximab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Jing Hao, PhD

CONTACT

18560082857; hedi0084@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2024
• First Posted: March 20, 2024
• Study Start: June 1, 2023
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2025
• Last Updated: March 20, 2024

Record last verified: 2024-02

Locations

CN (1)