A Single Arm, Open-label Clinical Trial to Evaluate the Efficacy and Safety of Maintenance Treatment With Capecitabine Plus Cetuximab in Metastatic Colorectal Cancer

Phase 2

• Conditions: Colorectal Neoplasms
• Interventions: Other: maintenance treatment with capecitabine plus cetuximab

• Registration Number: NCT02717923
• Lead Sponsor: Huazhong University of Science and Technology

Brief Summary

This is a single arm, open-label, multi-center clinical trial to evaluate the efficacy and safety of maintenance treatment with capecitabine plus cetuximab after first-line 5-fluorouracil-based chemotherapy plus cetuximab for patients with RAS wild-type metastatic colorectal cancer.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2016-03-18
• Study First Submitted QC: 2016-03-23
• Study First Posted: 2016-03-24
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-19
• Last Update Posted: 2017-10-23
• Primary Completion: 2019-01
• Study Completion: 2019-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Subjects has been fully understand this research and volunteered to sign the consent form;
2. Histologically and/or cytologically diagnosed with RAS wild-type metastatic metastatic colorectal cancer(Phase IIIc/IV), any other histological type is excluded;
3. Subjects with stable disease or better after induction treatment with eight to twelve 2-weekly cycles of 5FU-based standard chemotherapy;
4. ECOG Performance Status (ECOG PS) ≤1(0-1);
5. Evident measurable lesion(s) that meets the Response Evaluation Criteria in Solid Tumors (RECIST 1.1);
6. Expected survival>16 weeks.

Exclusion Criteria

1. Subjects with presence of clinically detectable second primary malignant tumors at the enrollment, or other malignant tumors within the last 5 years (excluding adequately treated skin basal cell carcinoma or carcinoma in situ of cervix);
2. Clinical refractory diseases(including uncontrolled epilepsy),and affect survivor;
3. Central Nervous System (CNS) metastatic disease or prior cerebral metastasis;
4. Researchers think that the subjects exist any clinical or laboratory abnormalities or compliance issues and not suitable to participate in this clinical study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Maintenance Treatment	maintenance treatment with capecitabine plus cetuximab	A single arm of maintenance treatment with capecitabine plus cetuximab after first-line 5-fluorouracil based standard chemotherapy plus cetuximab.

Primary Outcome Measures

Name	Time	Method
Progression-Free Survival of maintaining treatment（mPFS）	5 years	mPFS defined as time from randomisation to progression after maintenance

Trial Locations

Locations (1)

Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China