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

Maintenance Treatment With Capecitabine Plus Cetuximab After First-line 5-Fluorouracil-based Chemotherapy Plus Cetuximab for Patients With RAS Wild-type Metastatic Colorectal Cancer: a Single Arm, Open-label, Multi-center Clinical Trial

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02717923

Enrollment

Registered

2016-03-24

Start date

2014-01-31

Completion date

2019-06-30

Last updated

2017-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Neoplasms

Keywords

metastatic colorectal cancer, maintenance treatment, cetuximab

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.

Interventions

OTHERmaintenance treatment with capecitabine plus cetuximab

Using a maintenance treatment strategy of capecitabine plus cetuximab as a treatment option in mCRC after first-line 5-FU-based chemotherapy plus cetuximab

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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.

Design outcomes

Primary

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

Countries

China

Contacts

Primary ContactXianglin Yuan, Professional

yxl@medmail.com.cn13667241722

Backup ContactBen Zhao, Master

zhaoben0609@163.com15071206621

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026