CClinicalTrials.gg
RecruitingNCT06788171Updated Oct 1, 2026

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

A Phase 2 interventional study of Personalized Ultrafractionated Stereotactic Adaptive Radiotherapy and Bevacizumab in Colorectal Cancer Liver Metastasis, sponsored by Fujian Cancer Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-01.

Sponsored by Fujian Cancer Hospital · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started May 2026; still recruiting 4 months later.
Updated Oct 1, 2026Now RecruitingSite recruiting status changed+4 moreGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
35
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Colorectal Cancer Liver Metastasis
03

In context

Lead sponsor

Fujian Cancer Hospital is the lead sponsor of 155 studies on the registry; 90 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Age 18-75 years, any gender.
  2. Pathologically confirmed colorectal adenocarcinoma with liver metastases from colorectal cancer.
  3. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
  4. Adequate organ function, no contraindications to radiotherapy, or immunotherapy.
  5. Estimated life expectancy of more than 3 months.
  6. No obvious indications for emergent surgery due to primary tumor bleeding, obstruction, or similar conditions.
  7. At least one radiographically measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
  8. Microsatellite/mismatch repair status MSS/pMMR.
  9. No prior anti-tumor therapy for colorectal cancer, including radiotherapy, chemotherapy, or surgery.
  10. No prior immunotherapy.
  11. 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.
  12. Ability and willingness to comply with study visits, treatment schedules, laboratory testing, and other protocol-specified procedures throughout the study.
  13. Signed written informed consent.

Exclusion criteria

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
35 participants (estimated)

Study arms

  • 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 · Drug: Bevacizumab · Drug: Capecitabine · Drug: Oxaliplatin · Drug: Sintilimab

Interventions

  • RadiationPersonalized 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.

  • DrugBevacizumab

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

  • DrugCapecitabine

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

  • DrugOxaliplatin

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

  • DrugSintilimab

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

06

What researchers measure

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

07

Study locations

1 of 1 sites recruiting
  • Fujian Cancer Hospital
    Fuzhou, Fujian 350014, China
    • Sha Huang, MD · Contact · huangsha0210@163.com · +86-13763820570
    • MD · Contact
    • Sha Huang, MD · Principal investigator
    • Jinluan Li, MD · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Status
Not yet recruiting→Recruiting
changed Oct 1, 2026
Sites
Fujian Cancer Hospital is now Recruiting
Oct 1, 2026
Start date
Mar 1, 2025→May 9, 2026 (actual)
Oct 1, 2026
Primary completion
Dec 1, 2026→Sep 1, 2027
Oct 1, 2026
Study completion
Dec 1, 2026→Sep 1, 2027
Oct 1, 2026
Also revised
eligibility
Show all 1 update
  1. Oct 1, 2026
    Not yet recruiting→Recruiting
    Fujian Cancer Hospital is now Recruiting
    Start date Mar 1, 2025→May 9, 2026 (now actual)
    Primary completion Dec 1, 2026→Sep 1, 2027
    Study completion Dec 1, 2026→Sep 1, 2027
    Eligibility Criteria revised
    + 2 other changes: index terms and verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06788171
Lead sponsor
Fujian Cancer Hospital
Responsible party
Sponsor
First posted
Jan 23, 2025
Start date
May 9, 2026
Primary completion
Sep 1, 2027 (estimated)
Completion
Sep 1, 2027 (estimated)
Last update
Oct 1, 2026

Study contacts

Sha Huang, MD
Contact
huangsha0210@163.com
+86-13763820570
Jinluan Li, MD
Contact
lijinluan@fjmu.edu.cn
+86-15159628678

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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