Status:
RECRUITING
Combination of AK104 and Neoadjuvant Chemoradiotherapy in pMMR/MSS Locally Advanced Rectal Cancer
Lead Sponsor:
Sun Yat-sen University
Collaborating Sponsors:
Akeso
Haplox Biotechnology Co., Ltd.
Conditions:
Locally Advanced Rectal Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 loc...
Detailed Description
The study evaluates the addition of AK104(an Anti-PD1 and Anti-CTLA4 Bispecific Antibody) in neoadjuvant chemoradiotherapy in proficient Mismatch Repair (pMMR) /Microsatellite Stable (MSS) locally adv...
Eligibility Criteria
Inclusion
- Age 18-75
- ECOG 0-1
- Rectal adenocarcinoma
- cT3-4aNany or cT1-4aN+
- No distant metastasis
- Location ≤12 cm from the anal verge
- Positive PD-L1 expression (PD-L1 TPS≥1% or PD-L1 CPS ≥1)
- the MSI status is MSS and pMMR
- Sufficient bone marrow, kidney and liver function
- No previous surgery of the rectum, no previous chemotherapy, no previous pelvic radiation, no previous biotherapy, no immunotherapy
Exclusion
- bowel obstruction
- Distant metastasis
- Severe arrhythmia, cardiac dysfunction (NYHA grade III or IV )
- Uncontrollable severe hypertesion
- Active severe infection
- Cachexia, organ dysfunction
- Previous pelvic radiotherapy or chemotherapy
- Multiple primary cancers
- Epileptic seizures
- Malignant history within 5 years, except cervical carcinoma in situ or cutaneous basal cell carcinoma
- Persons deprived of liberty or under guardianship
- Impossibility for compliance to follow-up
- Certain or suspicious allergy to research drug
- Pregnant or breast-feeding woman
Key Trial Info
Start Date :
October 24 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2025
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT05980689
Start Date
October 24 2023
End Date
January 31 2025
Last Update
February 7 2024
Active Locations (1)
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1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060