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Trial Title:
Combination of AK104 and Neoadjuvant Chemoradiotherapy in pMMR/MSS Locally Advanced Rectal Cancer
NCT ID:
NCT05980689
Condition:
Locally Advanced Rectal Cancer
Conditions: Official terms:
Rectal Neoplasms
Capecitabine
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
AK104
Description:
During neo-CRT: 2 cycles of AK104, 10mg/kg d1 q3w. After neo-CRT: 3 cycles of AK104,
10mg/kg d1 q3w.
Arm group label:
Treatment Arm
Other name:
Cadonilimab
Intervention type:
Drug
Intervention name:
Capecitabine
Description:
During neo-CRT: 825mg/m2 bid Monday-Friday per week
Arm group label:
Treatment Arm
Intervention type:
Radiation
Intervention name:
Neoadjuvant Radiotherapy
Description:
IMRT DT: 50Gy/25Fx
Arm group label:
Treatment Arm
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.
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 advanced rectal cancer (LARC). A total of 33 pMMR/MSS LARC patients
will receive long-course chemoradiotherapy plus 2 cycles of AK104, followed by another 3
cycles of AK104, finally received clinical routine manage. The tumor response to
treatment, adverse effects and long-term prognosis will be analyzed.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Sun Yat-sen University Cancer Center
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Status:
Recruiting
Contact:
Last name:
WeiWei xiao
Phone:
8613710390520
Phone ext:
8613710390520
Email:
xiaoww@sysucc.org.cn
Start date:
October 24, 2023
Completion date:
January 31, 2025
Lead sponsor:
Agency:
Sun Yat-sen University
Agency class:
Other
Collaborator:
Agency:
Akeso
Agency class:
Industry
Collaborator:
Agency:
Haplox Biotechnology Co., Ltd.
Agency class:
Industry
Source:
Sun Yat-sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05980689
