- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04224415
Re-challenge of Anti-EGFR for Patients With RAS/BRAF Wild-type Metastatic CRC
February 13, 2023 updated by: Yuhong Li
Re-challenge of Anti-EGFR Agents for Chinese Patients With RAS/BRAF Wild-type Metastatic Colorectal Cancer
The aim of the trial is to study the efficacy and safety of Cetuximab re-challenge for Chinese Patients with RAS/BRAF wild-type Metastatic Colorectal Cancer.
Study Overview
Detailed Description
After first-line treatment of FOLFOX/FOLFIRI/FOLFOXIRI plus Cetuximab failure and defined as RAS/BRAF wild-type by molecular detection of cycle tumor DNA, the patients will be treated with Cetuximab and Irinotecan as a second-line or third-line treatment.
Study Type
Interventional
Enrollment (Actual)
35
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Guangdong
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Guangzhou, Guangdong, China, 510060
- Sun Yat-Sen University Cancer Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age ≥ 18 and ≤75.
- Diagnosed as colorectal adenocarcinoma by histology.
- Initially confirmed as RAS/BRAF wild type by tissue molecular detection.
- Treated with first-line therapy of FOLFOX/FOLFIRI/FOLFOXIRI+Cetuximab effectively and the PFS is not less than 6 months.
- Tumor progression during Cetuximab treatment or after treatment within 3 months.
- Tumor progression again after second-line treatment.
- The interval time of re-challenge is more than 4 months after the last time treated with Cetuximab.
- Lesions can be measured by the standard of RECIST v1.1.
- Defined as RAS/BRAF wild-type by molecular detection of cycle tumor DNA,
- No hematologic dysfunction(Platelets >90×10^9/L; WBC >3×10^9/L; Neutrophil >1.5×10^9/L;Hemoglobin >10 g/100ml).
- Serum bilirubin ≤ 1.5 × ULN; aminotransferase ≤ 5 × ULN.
- No ascites; no coagulation dysfunction; albumin ≥ 30g/L.
- Hepatic function was classified as class A by Child-Pugh classification.
- Serum creatinine < 1 × ULN, or creatinine clearance rate(CCR) > 50ml/ min(calculated by Cockcroft-Gault formula).
- ECOG scored as 0-2.
- Life expectancy > 3 months.
- Informed consent.
- Willing and able to receive follow-up until death or trial is finished or trial is terminated.
Exclusion Criteria:
- RAS/BRAF mutation.
- Severe arterial embolism or ascites.
- Presence of hemorrhagic tendency or coagulation dysfunction.
- Presence of hypertensive crisis or hypertensive encephalopathy.
- Severe uncontrolled systemic complications, such as infection or diabetes.
- Severe clinical CVD(cardiovascular disease), such as cerebrovascular accident(within 6 months before recruitment), myocardial infarction(within 6 months before recruitment), uncontrolled hypertension; unstable angina pectoris; congestive heart-failure(NYHA 2-4 grade); arrhythmia that needs medication treatment.
- Previous diagnosed or physical examination showed presence of central nervous system(CNS) disease(i.e. primary brain tumor, epilepsy uncontrolled by standard treatment, any history of brain metastases or stroke).
- Previous history of other malignancy within 5 years(except basal cell carcinoma after radical resection and/or cervical carcinoma in situ).
- Received any medication under research within 28 days before the trial.
- Any residual toxicity of previous chemotherapy(except hair loss), i.e. peripheral neuropathy ≥ NCI CTC v3.0 Grade 2, will be excluded from oxaliplatin-based chemotherapy regimen research pair.
- Allergic to any medication involved in the trial.
- Pregnant and lactating women.
- Patient who does not use or refuses to take any appropriate contraceptive measures (intrauterine contraceptive ring, barrier contraception combined with spermicidal gel or sterilization operation), including women of childbearing age (within 2 years after the last menstrual period) and men who are with possible fertility.
- Unable or unwilling to comply with the research plan.
- The existence of any other disease, dysfunction caused by metastatic lesions, or suspicious disease found on the regular examination, which indicating contraindications to the use of study drugs or may bring high risks of treatment related complications
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: C225+CPT-11
Patients will receive Systemic C225+CPT-11 every 14 days: C225 500 mg/m2 IV over 90 minutes on Day 1; Irinotecan 180 mg/m2 IV on Day 1 |
Patients will receive Systemic C225+CPT-11 every 14 days: C225 500 mg/m2 IV over 90 minutes on Day 1; Irinotecan 180 mg/m2 IV on Day 1 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective Response Rate
Time Frame: Up to 2-4 months
|
defined as complete remission rates and partial remission rates after treatment.
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Up to 2-4 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progress-free Survival(PFS)
Time Frame: Up to 2-4 months
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defined as the period from the date of receiving treatment to disease progress caused by any reason.
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Up to 2-4 months
|
Overall Survival(OS)
Time Frame: Up to 12 months
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defined as the period from the date of receiving treatment to death caused by any reason.
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Up to 12 months
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Adverse events(AE) and severe adverse events(SAE)
Time Frame: Up to 6 months
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defined as the incidence and severity of adverse events related to chemotherapy
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Up to 6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 31, 2020
Primary Completion (Actual)
December 31, 2021
Study Completion (Actual)
December 31, 2021
Study Registration Dates
First Submitted
January 8, 2020
First Submitted That Met QC Criteria
January 8, 2020
First Posted (Actual)
January 13, 2020
Study Record Updates
Last Update Posted (Actual)
February 15, 2023
Last Update Submitted That Met QC Criteria
February 13, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Colorectal Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Topoisomerase Inhibitors
- Topoisomerase I Inhibitors
- Irinotecan
Other Study ID Numbers
- Anti-EGFR Re-challenge
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
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