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Clinical Trials in China / NCT06788171
Starting soon Phase 2

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

NCT06788171 · tracked via the Priya Life Science China tracker
Sponsor
Fujian Cancer Hospital
Phase
Phase 2
Started
2025-03-01
Last updated
2025-01-23

Condition(s) studied

Colorectal Cancer Liver Metastasis

Investigational drug(s) / intervention(s)

Personalized Ultrafractionated Stereotactic Adaptive RadiotherapyBevacizumabCapecitabineOxaliplatinSintilimab

Personalized Ultrafractionated Stereotactic Adaptive Radiotherapy: PULSAR (SBRT): A targeted radiation therapy delivering 5-10 Gy/fraction every 3 weeks (q3w) to the gross tumor volume (GTV), for 3 times.

Bevacizumab: Bevacizumab: 5mg/kg, d1, q3w, 6 cycles.

Capecitabine: Capecitabine: 1000mg/m2, d1-14, bid, q3w, 6 cycles.

Oxaliplatin: Oxaliplatin: 130mg/m2, d1, q3w, 6 cycles.

Sintilimab: Sintilimab: 200mg, d1, q3w, 6 cycles.

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. Age 18-75 years, any gender. 2. Pathologically confirmed colorectal cancer with liver metastases (stage M1). 3. Karnofsky Performance Status ≥70. 4. Adequate organ function, no contraindications to radiotherapy, or immunotherapy. 5. Microsatellite/mismatch repair status MSS/pMMR. 6. No prior chemotherapy or any other anti-tumor treatment before inclusion. 7. No prior immunotherapy. 8. Ability to comply with the study protocol during the study period. 9. Signed written informed consent. Exclusion Criteria: 1. Pregnant or lactating women. 2. Pathological diagnosis of signet ring cell carcinoma. 3. History of other malignancies within the past 5 years, except cured skin cancer and cervical carcinoma in situ. 4. 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. 5. 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. 6. Organ transplant recipients requiring immunosuppressive therapy and long-term steroid users. 7. Patients with autoimmune diseases. 8. Severe uncontrolled recurrent infections or other severe uncontrolled comorbidities. 9. Subjects with baseline hematological and biochemical parameters not meeting the following criteria: hemoglobin ≥90g/L; absolute neutrophil count (ANC) .≥1.5×10\^9/L; platelets ≥100×10\^9/L; ALT, AST ≤2.5 times the upper limit of normal; ALP ≤2.5 times the upper limit of normal; serum total bilirubin \<1.5 times the upper limit of normal; serum creatinine \<1 times the upper limit of normal; serum albumin ≥30g/L. 10. Known deficiency of dihydropyrimidine dehydrogenase (DPD). 11. Allergy to any investigational drug components.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Fujian Cancer Hospital Fuzhou Fujian

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06788171 on ClinicalTrials.gov ↗ ← All trials in China