SCRT(Short Course Radiotherapy) Combined With CAPOX Plus QL1706 for Rectal Cancer Liver Metastases

Launched by FUJIAN CANCER HOSPITAL · Jan 16, 2025

Keywords

ClinConnect Summary

This clinical trial, called SCRT Combined With CAPOX Plus QL1706, is looking at a new way to treat locally advanced rectal cancer that has spread to the liver. The researchers hope that by using a combination of short course radiation therapy, chemotherapy, and immunotherapy, they can improve treatment outcomes for patients. This trial is currently not recruiting participants, but when it begins, it will be open to adults aged 18 to 75 who have been diagnosed with rectal cancer that has spread to the liver, and who meet certain health criteria.

To be eligible for this trial, participants must have a confirmed diagnosis of rectal cancer with liver metastases, be in relatively good health, and not have received prior cancer treatments like chemotherapy or immunotherapy. They should also be able to follow the study instructions and give their written consent to participate. If chosen, participants can expect to receive a combination of therapies while being closely monitored by the medical team. It's important to note that there are specific health conditions and medications that would disqualify someone from participating, so potential candidates should discuss their individual health situations with their doctors.

Gender

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Eligibility criteria

• Inclusion Criteria:
• • 1. Age 18-75 years, any gender.
• • 2. Pathologically confirmed rectal 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.