Chemotherapy With Cetuximab as Conversion Therapy in RAS/BRAF WT Unresectable Liver Metastasis Right-sided Colon Cancer
Doublet or Triplet Chemotherapy With Cetuximab as Conversion Therapy in RAS/BRAF Wild Type Unresectable Liver Metastasis Right-sided Colon Cancer With Curative Intent：Multi-center, Ambispective Observational Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Jing Hao, PhD
- Phone Number: 18560082857
- Email: hedi0084@hotmail.com
Study Locations
-
-
Shandong
-
Jinan, Shandong, China, 250012
- Recruiting
- Qilu Hospital of Shandong University
-
Contact:
- xiangling Wang, Dr.
- Phone Number: 8653182169841
- Email: xlwang71@163.com
-
Principal Investigator:
- Jing Hao
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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;
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 due to non-medical factors.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Doublet or triplet chemotherapy combined with cetuximab
|
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). |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
R0 resection rate
Time Frame: 1 year
|
R0 resection rate upon conversion treatment with chemotherapy plus cetuximab
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Progression free survival
Time Frame: 2 year
|
Time from date of randomization until the date of first documented progression or date of death from any cause, whichever came first.
|
2 year
|
|
Objective response rate
Time Frame: 1 year
|
CR + PR rate according to RECIST
|
1 year
|
|
Reported adverse events
Time Frame: 1 year
|
Number of patients with adverse events and severity according to NCI CTC 4.0
|
1 year
|
|
no evidence of disease
Time Frame: 1 year
|
the percentage of patients who had a curative liver treatment following protocol treatment
|
1 year
|
|
depth of response
Time Frame: 1 year
|
DOR means that the period from the day when either CR or PR is first confirmed until the day of documented PD or the day of death due to all causes, whichever occurs earlier.
|
1 year
|
|
Early Tumor Shrinkage
Time Frame: 1 year
|
Early tumor shrinkage assessed by Response rate at week 8
|
1 year
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KYLL-202304-31
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.