PULSAR Combined With PD-1 Ab and Chemotherapy Plus Bev. f... | NCT06788171

NCT06788171

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

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No data is available for this block.

Document Section

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No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Oversight Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PULSAR combined with PD-1 Ab and Bevacizumab plus Chemotherapy	Experimental	Interventions: Radiation: PULSAR(Personalized Ultrafractionated Stereotactic Adaptive Radiotherapy) Drug: Bevacizumab Drug: Capecitabine Drug: Oxaliplatin Drug: Sintilimab	Radiation: Personalized Ultrafractionated Stereotactic Adaptive Radiotherapy Drug: Bevacizumab Drug: Capecitabine Drug: Oxaliplatin Drug: Sintilimab

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

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

Eligibility Module

Eligibility Criteria

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.

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

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins