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

Sponsor
Fujian Cancer Hospital
Study ID
NCT06788171
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Colorectal Cancer Liver Metastasis

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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

Key Dates

First listed
Jan 23, 2025
Start date
Mar 1, 2025
Status verified
Jan 2025
Primary completion
Dec 1, 2026
Completion
Dec 1, 2026

Study Design

Enrollment
35 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

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

Primary Outcome Measure

Progression-free-Survival [ Time Frame: From enrollment to 36 month ]

Central Contacts