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

NCT07535632 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2026-04-17

No results posted yet for this study

Summary

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.

Conditions

  • Colorectal Neoplasms

Interventions

DRUG

Trifluridine and Tipiracil Tablets

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.

DRUG

Standard of Care (Investigator Selected)

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.

RADIATION

SBRT

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.

DRUG

Sintilimab

Anti-PD-1 monoclonal antibody administered at 200 mg intravenously every 2 weeks (Q2W) until disease progression or unacceptable toxicity.

DRUG

Bevacizumab

Anti-VEGF monoclonal antibody administered at 5 mg/kg intravenously every 2 weeks (Q2W) until disease progression or unacceptable toxicity.

Sponsors & Collaborators

  • Innovent Biologics (Suzhou) Co. Ltd.

    collaborator INDUSTRY

  • Shanghai Zhongshan Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2028-06-01
Completion
2028-06-01

Countries

  • China

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07535632 on ClinicalTrials.gov