A Phase Ⅱ/Ⅲ Clinical Trial of RC148 Plus Chemotherapy as 1L Therapy for Unresectable or Metastati… (NCT07462143) | Clinical Trial Compass
Not Yet RecruitingPhase 2/3
A Phase â…¡/â…¢ Clinical Trial of RC148 Plus Chemotherapy as 1L Therapy for Unresectable or Metastatic Colorectal Cancer
China700 participantsStarted 2026-04-30
Plain-language summary
This is a Phase â…¡/â…¢ 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)
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.