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

Fujian Provincial Cancer Hospital

Status and phase: Not yet enrolling; Phase 2

Conditions: Colorectal Cancer Liver Metastasis

Treatments: Drug: Sintilimab; Drug: Capecitabine; Radiation: Personalized Ultrafractionated Stereotactic Adaptive Radiotherapy; Drug: Oxaliplatin; Drug: Bevacizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT06788171

LIVERT

Details and patient eligibility

About

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

Enrollment: 35 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

PULSAR combined with PD-1 Ab and Bevacizumab plus Chemotherapy

Experimental group

Description:

Interventions: 1. Radiation: PULSAR(Personalized Ultrafractionated Stereotactic Adaptive Radiotherapy) 2. Drug: Bevacizumab 3. Drug: Capecitabine 4. Drug: Oxaliplatin 5. Drug: Sintilimab

Treatment:

Drug: Bevacizumab

Drug: Oxaliplatin

Radiation: Personalized Ultrafractionated Stereotactic Adaptive Radiotherapy

Drug: Sintilimab

Drug: Capecitabine