SBRT Followed by PD-1 Inhibitor, Bevacizumab and TAS-102 as Third-Line Therapy for Recurrent/Metastatic Colorectal Cancer

Sponsor
Shanghai Zhongshan Hospital
Study ID
NCT07535632
Phase
PHASE2
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • SBRT — RADIATION
    SBRT followed by triple therapy Stereotactic body radiotherapy (SBRT) delivered to metastatic lung or liver lesions using image-guided techniques. Biologically effective dose (BED) ≥94 Gy, completed within 1-2 weeks.
  • Sintilimab — DRUG
    Anti-PD-1 monoclonal antibody administered at 200 mg intravenously every 2 weeks (Q2W) until disease progression or unacceptable toxicity.
  • Bevacizumab — DRUG
    Anti-VEGF monoclonal antibody administered at 5 mg/kg intravenously every 2 weeks (Q2W) until disease progression or unacceptable toxicity.
  • Trifluridine and Tipiracil Tablets — DRUG
    Oral combination of trifluridine (a thymidine-based nucleoside analog) and tipiracil (a thymidine phosphorylase inhibitor). Given at 35 mg/m² twice daily on days 1-5 of each 14-day cycle until disease progression or unacceptable toxicity.
  • Standard of Care (Investigator Selected) — DRUG
    Investigator's choice of standard third-line therapy for metastatic colorectal cancer per Chinese Society of Clinical Oncology (CSCO) guidelines. Options may include trifluridine/tipiracil (TAS-102) monotherapy, TAS-102 plus bevacizumab, regorafenib, or fruquintinib. Administered until disease progression or unacceptable toxicity.

Study Details

This phase II trial studies how well stereotactic body radiotherapy (SBRT) followed by a combination of an immune checkpoint inhibitor (sintilimab), bevacizumab, and trifluridine/tipiracil (TAS-102) works as third-line treatment for patients with recurrent or metastatic colorectal cancer (mCRC) that has progressed after at least two prior lines of systemic therapy. The study will enroll 58 participants at Zhongshan Hospital, Fudan University. Participants will be randomly assigned (1:1) to either the experimental group or the control group. Those in the experimental group will receive SBRT to lung or liver metastases, followed one week later by sintilimab (200 mg every 2 weeks), bevacizumab (5 mg/kg every 2 weeks), and TAS-102 (35 mg/m² twice daily on days 1-5 every 2 weeks). Those in the control group will receive the investigator's choice of standard third-line therapy (such as TAS-102 alone or with bevacizumab, regorafenib, or fruquintinib). The main purpose is to see whether the new combination extends the time without the cancer growing or spreading (progression-free survival, PFS). Other goals include measuring overall survival, tumor response rates, local control of treated tumors, abscopal (out-of-field) effects, safety, quality of life, and exploring biomarkers that might predict treatment response. The study is expected to take 24 months to complete (12 months for enrollment and 12 months for follow-up). Results will help determine if adding SBRT and immunotherapy to standard chemotherapy and anti-angiogenic therapy is a beneficial option for patients with refractory mCRC.

Key Dates

First listed
Apr 17, 2026
Start date
Jun 1, 2026
Status verified
Apr 2026
Primary completion
Jun 1, 2028
Completion
Jun 1, 2028

Study Design

Enrollment
58 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: SBRT followed by triple therapy
    Patients receive stereotactic body radiotherapy (SBRT) to metastatic lung or liver lesions with a biologically effective dose (BED) ≥94 Gy, completed within 1-2 weeks. One week after SBRT, patients receive sintilimab 200 mg intravenously (IV) every 2 weeks (Q2W), bevacizumab 5 mg/kg IV Q2W, and trifluridine/tipiracil (TAS-102) 35 mg/m² orally twice daily on days 1-5 of each 14-day cycle. Treatment continues until disease progression, unacceptable toxicity, withdrawal of consent, or other protocol-specified discontinuation criteria.
  • Active Comparator: Standard of Care (SOC)
    Patients receive investigator's choice of standard-of-care third-line therapy for metastatic colorectal cancer, which may include trifluridine/tipiracil (TAS-102) monotherapy, TAS-102 plus bevacizumab, regorafenib, or fruquintinib, administered according to local clinical practice and Chinese Society of Clinical Oncology (CSCO) guidelines. Treatment continues until disease progression, unacceptable toxicity, withdrawal of consent, or other protocol-specified discontinuation criteria.

Primary Outcome Measure

Progression-Free Survival (PFS) [ Time Frame: Up to 24 months ]

Central Contacts

Related Studies