Combination of AK104 and Neoadjuvant Chemoradiotherapy in pMMR/MSS Locally Advanced Rectal Cancer

Launched by SUN YAT-SEN UNIVERSITY · Aug 5, 2023

Keywords

ClinConnect Summary

This clinical trial is testing a new treatment approach for patients with locally advanced rectal cancer. The study is examining the combination of a medication called AK104, which targets certain proteins involved in cancer growth, along with neoadjuvant chemoradiotherapy. This means that the treatment is given before surgery to help shrink the tumor. The researchers want to see how effective and safe this combination is for patients with a specific type of rectal cancer that has certain characteristics, such as positive PD-L1 expression.

To participate in this trial, patients must be between 18 and 75 years old and diagnosed with rectal adenocarcinoma that has not spread to distant parts of the body. Other important criteria include having good overall health and specific cancer markers. Participants can expect regular check-ups and monitoring during the study to ensure their safety and to assess how well the treatment is working. It's important to note that individuals with certain health issues or previous cancer treatments may not be eligible to join the trial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age 18-75
• • 2. ECOG 0-1
• • 3. Rectal adenocarcinoma
• • 4. cT3-4aNany or cT1-4aN+
• • 5. No distant metastasis
• • 6. Location ≤12 cm from the anal verge
• • 7. Positive PD-L1 expression (PD-L1 TPS≥1% or PD-L1 CPS ≥1)
• • 8. the MSI status is MSS and pMMR
• • 9. Sufficient bone marrow, kidney and liver function
• • 10. No previous surgery of the rectum, no previous chemotherapy, no previous pelvic radiation, no previous biotherapy, no immunotherapy
• Exclusion Criteria:
• • 1. bowel obstruction
• • 2. Distant metastasis
• • 3. Severe arrhythmia, cardiac dysfunction (NYHA grade III or IV )
• • 4. Uncontrollable severe hypertesion
• • 5. Active severe infection
• • 6. Cachexia, organ dysfunction
• • 7. Previous pelvic radiotherapy or chemotherapy
• • 8. Multiple primary cancers
• • 9. Epileptic seizures
• • 10. Malignant history within 5 years, except cervical carcinoma in situ or cutaneous basal cell carcinoma
• • 11. Persons deprived of liberty or under guardianship
• • 12. Impossibility for compliance to follow-up
• • 13. Certain or suspicious allergy to research drug
• • 14. Pregnant or breast-feeding woman