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

• Status: Recruiting
• Trial end date: 2025-01-31
• Target enrollment: 0
• Participant gender: All

Summary

This is an open-label, single-arm study to investigate the efficacy and safety of AK104 (an Anti-PD1 and Anti-CTLA4 Bispecific Antibody) and neoadjuvant chemoradiotherapy in patients with pMMR/MSS locally advanced rectal cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Collaborators: Akeso; Haplox Biotechnology Co., Ltd.
• Treatments: Capecitabine

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