RC148 plus chemotherapy as first-line treatment for unresectable or metastatic colorectal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase Ⅱ/Ⅲ interventional study evaluating the safety and efficacy of RC148 combined with capecitabine and oxaliplatin as a first-line treatment for unresectable or metastatic colorectal cancer. In Phase II, the trial assesses preliminary efficacy of RC148 plus chemotherapy. In Phase III, RC148 plus chemotherapy is compared head-to-head with bevacizumab plus chemotherapy for first-line treatment. Participants must have measurable disease, good performance status, and no prior systemic anti-tumor therapy for recurrent/metastatic disease. Biomarker tissue is required, and standard eligibility criteria apply including organ function and contraception guidelines for women of childbearing potential.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Voluntarily agree to participate in the study, sign the informed consent form, and be able to comply with the study protocol.
2. Aged 18-75 years old (including 18 years old and 75 years old).
3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
4. Expected survival period ≥ 12 weeks.
5. At least one measurable lesion according to RECIST v1.1 criteria.
6. 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.
7. Subjects must be able to provide tumor tissue samples for biomarker detection.
8. Adequate bone marrow, liver, kidney, and coagulation function.
9. 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.

Exclusion Criteria:

1. Known to have microsatellite instability-high (MSI-H) or deficient mismatch repair (dMMR).
2. Imaging shows obvious tumor necrosis or cavitation, and the investigator judges that participation in the study may increase the risk of bleeding.
3. Subjects with brain metastases.
4. Toxicities from prior anti-tumor therapy have not recovered to ≤ grade 1 according to NCI-CTCAE v6.0.
5. Known hypersensitivity or delayed-type allergy to any component of the study drug or similar drugs.
6. 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.
7. Subjects with acute, chronic, or symptomatic infections.
8. Subjects with diagnosed or suspected interstitial lung disease (ILD), drug-related pneumonia, radiation pneumonitis, severe impairment of lung function, or other lung diseases.
9. Subjects with active inflammatory bowel disease, a history of gastrointestinal perforation and/or fistula, or clinical symptoms of gastrointestinal obstruction.
10. Subjects with severe arterial/venous thromboembolic events within 6 months before randomization.
11. Active gastrointestinal bleeding, hemoptysis, peptic ulcer, or hemorrhagic events requiring intervention within 28 days before randomization; or presence of severe esophagogastric varices or epistaxis.
12. Presence of symptomatic or intervention-requiring third-space effusions.
13. Subjects with active or previously diagnosed autoimmune diseases that may recur.
14. History of other invasive malignant tumors within 5 years before randomization, or presence of any residual evidence of previously diagnosed malignant tumors.
15. Subjects who are pregnant, lactating, or planning to become pregnant.

Where it's running

• Beijing Cancer Hospital
  Beijing, Beijing Municipality, China Recruiting
• Beijing Friendship Hospital, Capital Medical University
  Beijing, Beijing Municipality, China Recruiting
• Chongqing University Cancer Hospital
  Chongqing, Chongqing Municipality, China Recruiting
• Fujian Medical University Union Hospital
  Fuzhou, Fujian, China Recruiting
• Meizhou People's Hospital
  Meizhou, Guangdong, China Recruiting
• Guangxi Medical University Cancer Hospital
  Nanjing, Guangxi, China Recruiting

Study contacts

• Study coordinator: Hongfang Li
• Email: hongfang.li@remegen.com
• Phone: 010-65018841

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Perioperative biomarker monitoring to spot complications after colorectal and gastric cancer surgery

  This randomized trial tests whether checking inflammatory and metabolic biomarkers during the perioperative period helps detect postoperative problems early in adults having colorectal or gastric cancer surgery.

  Recruiting Bucharest Emergency Hospital · Bucharest, Bucharest · NCT07881133

• Torvutatug samrotecan plus bevacizumab as first-line maintenance in non-HRD advanced epithelial ovarian cancer

  This trial tests whether adding torvu-samrotecan to bevacizumab after standard chemotherapy helps people with non-HRD advanced epithelial ovarian cancer live longer without the cancer worsening compared with bevacizumab alone.

  Recruiting at 4 sites Phase 3 AstraZeneca · Tamarac, Florida and 219 other locations · NCT07851025

• HAIC plus QL1706 and bevacizumab as first-line therapy for unresectable HER2-negative intrahepatic cholangiocarcinoma

  This study tests a liver-directed chemotherapy plus immune therapy and a blood vessel blocker to see if it helps people with unresectable intrahepatic cholangiocarcinoma.

  Recruiting Phase 2 Sun Yat-sen University · Guangzhou, Guangdong · NCT07841574

• Bevacizumab for severe HHT-related nosebleeds

  This study tests whether bevacizumab can help people with hereditary hemorrhagic telangiectasia who have severe nosebleeds.

  Recruiting Phase 2 Second Affiliated Hospital, Zhejiang University, School of Medicine · Hangzhou, Zhejiang · NCT07828015

• Torvutatug samrotecan with or without bevacizumab as maintenance in platinum-sensitive relapsed epithelial ovarian, fallopian tube, or primary peritoneal cancer

  This study tests torvutatug samrotecan, with or without bevacizumab, to see if it helps people with platinum-sensitive relapsed ovarian, fallopian tube, or primary peritoneal cancer stay cancer-free longer after their last platinum therapy.

  Recruiting at 3 sites Phase 3 AstraZeneca · Anchorage, Alaska and 123 other locations · NCT07816666

• Trastuzumab plus bevacizumab vs bevacizumab alone as first-line maintenance therapy for ovarian cancer

  This trial tests whether adding trastuzumab to bevacizumab maintenance helps people with epithelial ovarian cancer after initial platinum-based therapy.

  Recruiting at 3 sites Phase 3 Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Beijing, Beijing Municipality and 2 other locations · NCT07779538

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.