A Phase Ⅱ/Ⅲ Clinical Trial of RC148 Plus Chemotherapy as 1L Therapy for Unresectable or Metastatic Colorectal Cancer
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
1 other identifier
interventional
700
1 country
19
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2026
Longer than P75 for phase_2
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 4, 2026
CompletedFirst Posted
Study publicly available on registry
March 10, 2026
CompletedStudy Start
First participant enrolled
April 30, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2030
March 10, 2026
February 1, 2026
1.7 years
March 4, 2026
March 4, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Objective Response Rate (ORR)
Objective Response Rate (ORR) assessed by the investigator according to RECIST v1.1
24 months
Secondary Outcomes (5)
Duration of Response (DoR)
24 months
Disease Control Rate (DCR)
24 months
Time to Response (TTR)
24 months
Overall Survival (OS)
36 months
AEs/SAE
36 months
Study Arms (2)
Experimental Group 1
EXPERIMENTALDrug: RC148 （Dose1） in combination with CAPEOX
Experimental Group 2
EXPERIMENTALDrug: RC148 RC148 (Dose 2) in combination with CAPEOX
Interventions
RC148 (Dose 1) plus Capecitabine and Oxaliplatin
RC148 (Dose 2) plus Capecitabine and Oxaliplatin
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Meizhou People's Hospital
Meizhou, Guangdong, China
Guangxi Medical University Cancer Hospital
Nanjing, Guangxi, China
The Fourth Hospital of Hebei Medical University and Hebei Tumor Hospital
Shijiazhuang, Hebei, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
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 Cancer Hospital
Nanjing, Jiangsu, China
Affiliated Hospital of Jiangnan University
Wuxi, Jiangsu, China
The first hospital of Jilin University
Changchun, Jilin, China
Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Shanxi Cancer Hospital
Taiyuan, Shanxi, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
People's Hospital of Tianjin
Tianjin, Tianjin Municipality, China
Yunnan Cancer Hospital
Kunming, Yunnan, China
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- The Phase II of this study is designed to be a randomized and open - label trial. The Phase III is a randomized and double - blind study, in which neither the researchers nor the subjects know the type of investigational drug given in addition to chemotherapy.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 4, 2026
First Posted
March 10, 2026
Study Start
April 30, 2026
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
December 31, 2030
Last Updated
March 10, 2026
Record last verified: 2026-02