Not Yet RecruitingPhase 2

PULSAR Combined With PD-1 Ab and Chemotherapy Plus Bev. for CRLM

China35 participantsStarted 2025-03-01

Plain-language summary

To explore Progression-Free-Survival(FPS) of PULSAR(personalized ultrafractionated stereotactic adaptive radiotherapy) combined with PD-1 Ab and Chemotherapy plus Bevacizumabfor CRLM

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Age 18-75 years, any gender.
✓. Pathologically confirmed colorectal cancer with liver metastases (stage M1).
✓. Karnofsky Performance Status ≥70.
✓. Adequate organ function, no contraindications to radiotherapy, or immunotherapy.
✓. Microsatellite/mismatch repair status MSS/pMMR.
✓. No prior chemotherapy or any other anti-tumor treatment before inclusion.
✓. No prior immunotherapy.
✓. Ability to comply with the study protocol during the study period.

Exclusion criteria

✕. Pregnant or lactating women.
✕. Pathological diagnosis of signet ring cell carcinoma.
✕. History of other malignancies within the past 5 years, except cured skin cancer and cervical carcinoma in situ.
✕. Uncontrolled epilepsy, central nervous system disorders, or history of psychiatric disorders that, in the opinion of the investigator, may interfere with signing the informed consent form or affect patient compliance with oral medication.
✕. Clinically significant (i.e., active) cardiac disease, such as symptomatic coronary artery disease, New York Heart Association (NYHA) Class II or greater congestive heart failure, or significant arrhythmias requiring drug intervention (see Appendix 12), or history of myocardial infarction within the past 12 months.
✕. Organ transplant recipients requiring immunosuppressive therapy and long-term steroid users.
✕. Patients with autoimmune diseases.
✕. Severe uncontrolled recurrent infections or other severe uncontrolled comorbidities.

What they're measuring

Progression-free-Survival

Timeframe: From enrollment to 36 month

Trial details

NCT IDNCT06788171

SponsorFujian Cancer Hospital

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2026-12-01

Contact for this trial

Sha Huang, MD

+86-13763820570 huangsha0210@163.com

View on ClinicalTrials.gov More Colorectal Cancer Liver Metastasis trials