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

Launched by FUJIAN CANCER HOSPITAL · Jan 18, 2025

Keywords

ClinConnect Summary

This clinical trial, called PULSAR, is investigating a new treatment approach for patients with colorectal cancer that has spread to the liver. The study will look at how well a combination of personalized radiation therapy, an immune therapy called PD-1 antibody, chemotherapy, and a medication called Bevacizumab can help improve the time patients live without their cancer getting worse, known as progression-free survival.

To be eligible for this trial, participants should be between 18 and 75 years old and have been diagnosed with colorectal cancer that has spread to the liver. They must also be in good overall health, meaning they can carry out daily activities without major issues. Importantly, they should not have received other cancer treatments before joining the study. If you or a loved one qualifies and decides to participate, you can expect regular check-ups and monitoring throughout the trial to track how well the treatment is working and any side effects that may arise. The trial is not yet open for recruitment, but it holds promise for improving treatment options for this challenging condition.

Gender

ALL

Eligibility criteria

• 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.