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

NCT ID: NCT06788171

Last Updated: 2025-01-23

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-01
• Study Completion Date: 2026-12-01

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

Conditions

Colorectal Cancer Liver Metastasis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PULSAR combined with PD-1 Ab and Bevacizumab plus Chemotherapy

Interventions:

1. Radiation: PULSAR(Personalized Ultrafractionated Stereotactic Adaptive Radiotherapy)

2. Drug: Bevacizumab

3. Drug: Capecitabine

4. Drug: Oxaliplatin

5. Drug: Sintilimab

Group Type: EXPERIMENTAL

Personalized Ultrafractionated Stereotactic Adaptive Radiotherapy

Intervention Type: RADIATION

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

Intervention Type: DRUG

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

Capecitabine

Intervention Type: DRUG

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

Oxaliplatin

Intervention Type: DRUG

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

Sintilimab

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: RADIATION

Bevacizumab

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

Intervention Type: DRUG

Capecitabine

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

Intervention Type: DRUG

Oxaliplatin

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

Intervention Type: DRUG

Sintilimab

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fujian Cancer Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fujian Cancer Hospital

Fuzhou, Fujian, China

Countries

China

Central Contacts

Sha Huang, MD

Role: CONTACT

huangsha0210@163.com

+86-13763820570

Jinluan Li, MD

Role: CONTACT

lijinluan@fjmu.edu.cn

+86-15159628678

Facility Contacts

Sha Huang, MD

Role: primary

huangsha0210@163.com

+86-13763820570

MD

Role: backup

Other Identifiers

LIVERT

Identifier Type: -

Identifier Source: org_study_id