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

Last updated: March 13, 2024
Sponsor: Qilu Hospital of Shandong University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Colorectal Cancer

Colon Cancer

Treatment

Doublet or triplet chemotherapy combined with cetuximab

Clinical Study ID

NCT06322147
KYLL-202304-31
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Signed informed consent obtained before any study specific procedures. Subjects mustbe 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 withmolecular testing RAS/BRAF wild-type, MSS;
  • At least one measurable lesion in liver metastases according to Response EvaluationCriteria in Solid Tumors (RECIST) criteria version 1.1;
  • No previous any systemic anticancer therapy; if received primary tumor surgery andpostoperative adjuvant chemotherapy, more than 6 months from the end of the lastchemotherapy;
  • Liver metastases are initially unresectable, but can have the opportunity to achievecomplete resection or NED status with conversion therapy;
  • Patients have adequate bone marrow, hepatic and renal function;

Exclusion

Exclusion Criteria:

  • 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 dueto non-medical factors.

Study Design

Total Participants: 50
Treatment Group(s): 1
Primary Treatment: Doublet or triplet chemotherapy combined with cetuximab
Phase:
Study Start date:
June 01, 2023
Estimated Completion Date:
December 30, 2025

Study Description

Patients with colorectal liver-limited metastases (CLM) represent an exceptional subgroup with regards to the possible benefits of potentially curative multidisciplinary strategies, in which the upfront most active combination regimens are preferred to improve the rate of radical resection (R0) and NED (no evidence of disease). Unfortunately, Data are limited that specifically address the tumor location's impact on conversion therapy. As far as right-sided CRLM are concerned, much lower R0 after conversion therapy could be achieved when compared with left-sided CRLM. Furthermore, great controversies remain about the optimal conversion regimens in right-sided CRLM and the potential roles of anti-EGFR with regards to the different recommendations from NCCN, ESMO and CSCO guidelines. Chemotherapy plus cetuximab have the advantages in terms of response rate, early tumor shrinkage and depth of response, thus it is still of great value to explore the roles of cetuximab plus chemotherapy as conversion strategy in the right-sided RAS/BRAF wild type and MSS CRLM in the real world scenario.

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.

Connect with a study center

  • Qilu hospital of Shandong University

    Jinan, Shandong 250012
    China

    Active - Recruiting

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