Clinical trial · Interventional
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
NCT06788171CI-TRIAL-00084998not yet recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To explore Progression-Free-Survival(FPS) of PULSAR(personalized ultrafractionated stereotactic adaptive radiotherapy) combined with PD-1 Ab and Chemotherapy plus Bevacizumabfor CRLM
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer Liver Metastasis | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| Capecitabine | Drug | Capecitabine | ALIAS |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
| Personalized Ultrafractionated Stereotactic Adaptive Radiotherapy | Radiation | — | UNRESOLVED |
| Sintilimab | Drug | Sintilimab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PULSAR combined with PD-1 Ab and Bevacizumab plus Chemotherapy
- description
- Interventions: 1. Radiation: PULSAR(Personalized Ultrafractionated Stereotactic Adaptive Radiotherapy) 2. Drug: Bevacizumab 3. Drug: Capecitabine 4. Drug: Oxaliplatin 5. Drug: Sintilimab
- interventionNames
- Radiation: Personalized Ultrafractionated Stereotactic Adaptive Radiotherapy
- Drug: Bevacizumab
- Drug: Capecitabine
- Drug: Oxaliplatin
- Drug: Sintilimab
Primary outcomes (1)
- measure
- Progression-free-Survival
- timeFrame
- From enrollment to 36 month
Secondary outcomes (3)
- measure
- Adverse Reactions
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age 18-75 years, any gender. 2. Pathologically confirmed colorectal cancer with liver metastases (stage M1). 3. Karnofsky Performance Status ≥70. 4. Adequate organ function, no contraindications to radiotherapy, or immunotherapy. 5. Microsatellite/mismatch repair status MSS/pMMR. 6. No prior chemotherapy or any other anti-tumor treatment before inclusion. 7. No prior immunotherapy. 8. Ability to comply with the study protocol during the study period. 9. Signed written informed consent. 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.
References
Publications (0)
Data not yet available
No reference posted for this study.