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

January 18, 2025 updated by: Fujian Cancer Hospital

A Phase II Trial of PULSAR (Personalized Ultrafractionated Stereotactic Adaptive Radiotherapy) Combined With PD-1 Ab and Chemotherapy Plus Bevacizumab for Colorectal Cancer Liver Metastasis

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

35

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China, 350014
        • Fujian Cancer Hospital
        • Contact:
          • MD
        • Principal Investigator:
          • Jinluan Li, MD
        • Contact:
        • Principal Investigator:
          • Sha Huang, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Radiation: 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.
Drug: Bevacizumab
Bevacizumab: 5mg/kg, d1, q3w, 6 cycles.
Drug: Capecitabine
Capecitabine: 1000mg/m2, d1-14, bid, q3w, 6 cycles.
Drug: Oxaliplatin
Oxaliplatin: 130mg/m2, d1, q3w, 6 cycles.
Drug: Sintilimab
Sintilimab: 200mg, d1, q3w, 6 cycles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression-free-Survival
Time Frame: From enrollment to 36 month
From enrollment to 36 month

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse Reactions
Time Frame: From enrollment to 36 month
From enrollment to 36 month
Overall Survival (OS)
Time Frame: From enrollment to 36 month
From enrollment to 36 month
Objective Response Rate (ORR)
Time Frame: From enrollment to 36 month
From enrollment to 36 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fujian Cancer Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

January 14, 2025

First Submitted That Met QC Criteria

January 18, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 18, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LIVERT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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