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

Phase 2

Not yet recruiting

• Conditions: Colorectal Cancer Liver Metastasis
• Interventions: Radiation: Personalized Ultrafractionated Stereotactic Adaptive Radiotherapy; Drug: Bevacizumab; Drug: Capecitabine; Drug: Oxaliplatin; Drug: Sintilimab

• Registration Number: NCT06788171
• Lead Sponsor: Fujian Cancer Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-14
• Study First Submitted QC: 2025-01-18
• Last Update Submitted: 2025-01-18
• Study First Posted: 2025-01-23
• Last Update Posted: 2025-01-23
• Study Start: 2025-03-01
• Primary Completion: 2026-12-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 35

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PULSAR combined with PD-1 Ab and Bevacizumab plus Chemotherapy	Personalized Ultrafractionated Stereotactic Adaptive Radiotherapy	Interventions: 1. Radiation: PULSAR(Personalized Ultrafractionated Stereotactic Adaptive Radiotherapy) 2. Drug: Bevacizumab 3. Drug: Capecitabine 4. Drug: Oxaliplatin 5. Drug: Sintilimab
PULSAR combined with PD-1 Ab and Bevacizumab plus Chemotherapy	Bevacizumab	Interventions: 1. Radiation: PULSAR(Personalized Ultrafractionated Stereotactic Adaptive Radiotherapy) 2. Drug: Bevacizumab 3. Drug: Capecitabine 4. Drug: Oxaliplatin 5. Drug: Sintilimab
PULSAR combined with PD-1 Ab and Bevacizumab plus Chemotherapy	Capecitabine	Interventions: 1. Radiation: PULSAR(Personalized Ultrafractionated Stereotactic Adaptive Radiotherapy) 2. Drug: Bevacizumab 3. Drug: Capecitabine 4. Drug: Oxaliplatin 5. Drug: Sintilimab
PULSAR combined with PD-1 Ab and Bevacizumab plus Chemotherapy	Oxaliplatin	Interventions: 1. Radiation: PULSAR(Personalized Ultrafractionated Stereotactic Adaptive Radiotherapy) 2. Drug: Bevacizumab 3. Drug: Capecitabine 4. Drug: Oxaliplatin 5. Drug: Sintilimab
PULSAR combined with PD-1 Ab and Bevacizumab plus Chemotherapy	Sintilimab	Interventions: 1. Radiation: PULSAR(Personalized Ultrafractionated Stereotactic Adaptive Radiotherapy) 2. Drug: Bevacizumab 3. Drug: Capecitabine 4. Drug: Oxaliplatin 5. Drug: Sintilimab

Primary Outcome Measures

Name	Time	Method
Progression-free-Survival	From enrollment to 36 month

Secondary Outcome Measures

Name	Time	Method
Adverse Reactions	From enrollment to 36 month
Overall Survival (OS)	From enrollment to 36 month
Objective Response Rate (ORR)	From enrollment to 36 month

Trial Locations

Locations (1)

Fujian Cancer Hospital; 🇨🇳 Fuzhou, Fujian, China