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NCT06788171RecruitingPhase 2

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

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

Source: ClinicalTrials.gov · Last updated 1 Oct 2026

Brief summary (registry, in English)

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

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
35 (estimated)
First submitted
14 Jan 2025
Start date
9 May 2026
Primary completion date
1 Sept 2027
Lead sponsor
Fujian Cancer Hospital
NCT number
NCT06788171

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 35
  • From 9 May 2026 to the primary completion date, 1 Sept 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Organ transplant recipients requiring immunosuppressive therapy and long-term steroid users.
  • Allergy to any investigational drug components.

Other illness

  • 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.
  • Patients with autoimmune diseases.
  • Severe uncontrolled recurrent infections or other severe uncontrolled comorbidities.

Lab values

  • 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.

Other

  • Pregnant or lactating women.
  • Pathological diagnosis of signet ring cell carcinoma.
  • Known deficiency of dihydropyrimidine dehydrogenase (DPD).

Who the study is looking for

  • Age 18-75 years, any gender.
  • Pathologically confirmed colorectal adenocarcinoma with liver metastases from colorectal cancer.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
  • Adequate organ function, no contraindications to radiotherapy, or immunotherapy.
  • Estimated life expectancy of more than 3 months.
  • No obvious indications for emergent surgery due to primary tumor bleeding, obstruction, or similar conditions.
  • At least one radiographically measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
  • Microsatellite/mismatch repair status MSS/pMMR.
  • No prior anti-tumor therapy for colorectal cancer, including radiotherapy, chemotherapy, or surgery.
  • No prior immunotherapy.
  • Women of childbearing potential or men with partners of childbearing potential agree to use highly effective contraception (annual failure rate \<1%) from 7 days before the first dose through 24 weeks after the last dose.
  • Ability and willingness to comply with study visits, treatment schedules, laboratory testing, and other protocol-specified procedures throughout the study.
  • Signed written informed consent.

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Fujian Cancer Hospital
Coordinator of this site? Confirm its status
FuzhouChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.