Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06788171

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

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

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Fujian Cancer Hospital

Fuzhou, Fujian, 350014, China

Location contact

Jinluan Li, MD

PRINCIPAL_INVESTIGATOR

MD

CONTACT

Sha Huang, MD

CONTACT

[email protected]

+86-13763820570

Sha Huang, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 chemotherapy or any other anti-tumor treatment before inclusion.
  • No prior immunotherapy.
  • Ability to comply with the study protocol during the study period.
  • Signed written informed consent.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Bevacizumab

Drug

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

Capecitabine

Drug

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

Oxaliplatin

Drug

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

Sintilimab

Drug

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

Primary outcomes

  1. Progression-free-Survival

    Time frame: From enrollment to 36 month

Secondary outcomes

  1. Adverse Reactions

    Time frame: From enrollment to 36 month

  2. Overall Survival (OS)

    Time frame: From enrollment to 36 month

  3. Objective Response Rate (ORR)

    Time frame: From enrollment to 36 month

Study contacts

Contact information is provided by the study sponsor or research team.

Jinluan Li, MD

CONTACT

[email protected]

+86-15159628678

Sha Huang, MD

CONTACT

[email protected]

+86-13763820570

Sponsors and collaborators

Lead sponsor

Fujian Cancer Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 23, 2025
Registry last updated
Jan 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.