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

NCT06788171 | Not Yet Recruiting Phase 2

• 1 other identifier: LIVERT
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Progression-free-Survival

  From enrollment to 36 month

Secondary Outcomes (3)

• Adverse Reactions

  From enrollment to 36 month

• Overall Survival (OS)

  From enrollment to 36 month

• Objective Response Rate (ORR)

  From enrollment to 36 month

Study Arms (1)

PULSAR combined with PD-1 Ab and Bevacizumab plus Chemotherapy

EXPERIMENTAL

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

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

Interventions

Personalized Ultrafractionated Stereotactic Adaptive Radiotherapy 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.

PULSAR combined with PD-1 Ab and Bevacizumab plus Chemotherapy

Bevacizumab DRUG

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

PULSAR combined with PD-1 Ab and Bevacizumab plus Chemotherapy

Capecitabine DRUG

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

PULSAR combined with PD-1 Ab and Bevacizumab plus Chemotherapy

Oxaliplatin DRUG

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

PULSAR combined with PD-1 Ab and Bevacizumab plus Chemotherapy

Sintilimab DRUG

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

PULSAR combined with PD-1 Ab and Bevacizumab plus Chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 immunotherapy.
• Ability to comply with the study protocol during the study period.
• Signed written informed consent.

You may not qualify if:

• 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.
• 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.
• Known deficiency of dihydropyrimidine dehydrogenase (DPD).
• Allergy to any investigational drug components.

Sponsors & Collaborators

• Fujian Cancer Hospital: lead

Study Sites (1)

Fujian Cancer Hospital

Fuzhou, Fujian, 350014, China

Location

MeSH Terms

Interventions

Bevacizumab; Capecitabine; Oxaliplatin; sintilimab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Coordination Complexes; Organic Chemicals

Central Study Contacts

Sha Huang, MD

CONTACT

+86-13763820570; huangsha0210@163.com

Jinluan Li, MD

CONTACT

+86-15159628678; lijinluan@fjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2025
• First Posted: January 23, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 23, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)