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Clinical Trial NCT07462143 for Colorectal (Colon or Rectal) Cancer is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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A Phase Ⅱ/Ⅲ Clinical Trial of RC148 Plus Chemotherapy as 1L Therapy for Unresectable or Metastatic Colorectal Cancer Phase 2, Phase 3 700
Clinical Trial NCT07462143 is designed to study Treatment for Colorectal (Colon or Rectal) Cancer. This Phase 2 Phase 3 interventional study is not yet recruiting. Enrollment is planned to begin on 30 April 2026 until the study accrues 700 participants. Led by RemeGen Co., Ltd., this study is expected to complete by 31 December 2030. The latest data from ClinicalTrials.gov was last updated on 10 March 2026.
Brief Summary
This is a Phase Ⅱ/Ⅲ study. The purpose of this study is to evaluate the efficacy and safety of RC148 combined with chemotherapy for the first-line treatment of unresectable metastatic colorectal cancer (CRC)
Detailed Description
Primary objective in Phase II: To preliminarily evaluate the efficacy of RC148 combined with chemotherapy as first - line treatment for unresectable or metastatic CRC.
Primary objective in Phase III: To evaluate the efficacy of RC148 combined with chemotherapy compared with bevacizumab combined with chemotherapy as first - line treatment for unresectable or metastatic CRC.
Official Title
A Randomized, Multicenter, Phase Ⅱ/Ⅲ Study of RC148 Combined With Chemotherapy Versus Bevacizumab Combined With Chemotherapy as First-line Treatment for Unresectable or Metastatic Colorectal Cancer
Conditions
Colorectal (Colon or Rectal) CancerOther Study IDs
- RC148-C303
NCT ID Number
Start Date (Actual)
2026-04-30
Last Update Posted
2026-03-10
Completion Date (Estimated)
2030-12-31
Enrollment (Estimated)
700
Study Type
Interventional
PHASE
Phase 2
Phase 3
Phase 3
Status
Not yet recruiting
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalExperimental Group 1 Drug: RC148 （Dose1） in combination with CAPEOX | RC148 (Dose 1) plus Capecitabine and Oxaliplatin RC148 (Dose 1) plus Capecitabine and Oxaliplatin |
ExperimentalExperimental Group 2 Drug: RC148 RC148 (Dose 2) in combination with CAPEOX | RC148 (Dose 2) plus Capecitabine and Oxaliplatin RC148 (Dose 2) plus Capecitabine and Oxaliplatin |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Objective Response Rate (ORR) | Objective Response Rate (ORR) assessed by the investigator according to RECIST v1.1 | 24 months |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Duration of Response (DoR) | Duration of Response (DoR) assessed by the investigator according to RECIST v1.1 | 24 months |
Disease Control Rate (DCR) | Disease Control Rate (DCR) assessed by the investigator according to RECIST v1.1 | 24 months |
Time to Response (TTR) | Time to Response (TTR) assessed by the investigator according to RECIST v1.1 | 24 months |
Overall Survival (OS) | OS | 36 months |
AEs/SAE | The incidence and severity of adverse events / serious adverse events | 36 months |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- Voluntarily agree to participate in the study, sign the informed consent form, and be able to comply with the study protocol.
- Aged 18-75 years old (including 18 years old and 75 years old).
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- Expected survival period ≥ 12 weeks.
- At least one measurable lesion according to RECIST v1.1 criteria.
- Histologically or cytologically confirmed colorectal adenocarcinoma, judged by the investigator as unsuitable for curative treatment, and no prior systemic anti-tumor treatment in the recurrent or metastatic stage.
- Subjects must be able to provide tumor tissue samples for biomarker detection.
- Adequate bone marrow, liver, kidney, and coagulation function.
- Female subjects of childbearing potential must agree to use at least one medically approved contraceptive method during the study treatment and for 6 months after the end of the study treatment, and must have a negative blood pregnancy test within 7 days before study enrollment; male subjects must agree to use at least one medically approved contraceptive method during the study treatment and for 6 months after the end of the study treatment.
- Known to have microsatellite instability-high (MSI-H) or deficient mismatch repair (dMMR).
- Imaging shows obvious tumor necrosis or cavitation, and the investigator judges that participation in the study may increase the risk of bleeding.
- Subjects with brain metastases.
- Toxicities from prior anti-tumor therapy have not recovered to ≤ grade 1 according to NCI-CTCAE v6.0.
- Known hypersensitivity or delayed-type allergy to any component of the study drug or similar drugs.
- Subjects with refractory nausea and vomiting, chronic gastrointestinal diseases, or other diseases that may interfere the adequate absorption, distribution, metabolism, or excretion of oral drugs.
- Subjects with acute, chronic, or symptomatic infections.
- Subjects with diagnosed or suspected interstitial lung disease (ILD), drug-related pneumonia, radiation pneumonitis, severe impairment of lung function, or other lung diseases.
- Subjects with active inflammatory bowel disease, a history of gastrointestinal perforation and/or fistula, or clinical symptoms of gastrointestinal obstruction.
- Subjects with severe arterial/venous thromboembolic events within 6 months before randomization.
- Active gastrointestinal bleeding, hemoptysis, peptic ulcer, or hemorrhagic events requiring intervention within 28 days before randomization; or presence of severe esophagogastric varices or epistaxis.
- Presence of symptomatic or intervention-requiring third-space effusions.
- Subjects with active or previously diagnosed autoimmune diseases that may recur.
- History of other invasive malignant tumors within 5 years before randomization, or presence of any residual evidence of previously diagnosed malignant tumors.
- Subjects who are pregnant, lactating, or planning to become pregnant.
RemeGen Co., Ltd.Study Central Contact
Contact: Hongfang Li, 010-65018841, [email protected]
19 Study Locations in 1 Countries
Beijing Municipality
Beijing Cancer Hospital, Beijing, Beijing Municipality, China
Beijing Friendship Hospital, Capital Medical University, Beijing, Beijing Municipality, China
Chongqing Municipality
Chongqing Cancer Hospital, Chongqing, Chongqing Municipality, China
Fujian
Fujian Medical University Union Hospital, Fuzhou, Fujian, China
Guangdong
Meizhou People's Hospital, Meizhou, Guangdong, China
Guangxi
Guangxi Medical University Cancer Hospital, Nanjing, Guangxi, China
Hebei
The Fourth Hospital of Hebei Medical University and Hebei Tumor Hospital, Shijiazhuang, Hebei, China
Henan
The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China
Hubei
Tongji Medical College of Huazhong University of Science &Technology, Wuhan, Hubei, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology, Wuhan, Hubei, China
Jiangsu
Jiangsu Cancer Hospital, Nanjing, Jiangsu, China
Affiliated Hospital of Jiangnan University, Wuxi, Jiangsu, China
Jilin
The first hospital of Jilin University, Changchun, Jilin, China
Shanghai Municipality
Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, Shanghai Municipality, China
Shanxi
Shanxi Cancer Hospital, Taiyuan, Shanxi, China
Sichuan
West China Hospital of Sichuan University, Chengdu, Sichuan, China
Tianjin Municipality
People's Hospital of Tianjin, Tianjin, Tianjin Municipality, China
Yunnan
Yunnan Cancer Hospital, Kunming, Yunnan, China
Zhejiang
The Second Affiliated Hospital Zhejiang University School of Medicine, Hangzhou, Zhejiang, China