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Combination of AK104 and Neoadjuvant Chemoradiotherapy in pMMR/MSS Locally Advanced Rectal Cancer | Clinical Trials | Clareo Health

UNKNOWNPHASE2

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

A Phase II Trial of AK104 Combined With Neoadjuvant Chemoradiotherapy in Proficient Mismatch Repair/Microsatellite Stable Locally Advanced Rectal Cancer

NCT05980689•Sun Yat-sen University

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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
+4 more criteria

Locations (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Key Dates

Start Date

October 24, 2023

Primary Completion Date

June 30, 2024

Completion Date

January 31, 2025

Last Updated

February 7, 2024

Enrollment

ESTIMATED participants

Conditions

Locally Advanced Rectal Cancer

Interventions

AK104

DRUG

Capecitabine

DRUG

Neoadjuvant Radiotherapy

RADIATION

Contacts

WeiWei Xiao

CONTACT

8613710390520 xiaoww@sysucc.org.cn

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RECRUITINGPHASE2

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RECRUITINGPHASE2

Consolidation Versus Induction Chemotherapy in Total Neoadjuvant Therapy of Rectal Cancer With High Risk for Recurrence

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 7, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

SMART TNT for the Conservative Management of Locally Advanced Rectal Cancer

Node-sparing Radiotherapy Combined with Total Neoadjuvant CAPOX and Sintilimab for MSS Middle and Low Rectal Cancer

Consolidation Versus Induction Chemotherapy in Total Neoadjuvant Therapy of Rectal Cancer With High Risk for Recurrence

A Pospective, Single-arm, Multicenter Clinical Trial Evaluating Preoperative Neoadjuvant mFOLFOX6 Chemotherapy in Combination With PD1 Monoclonal Antibody in MSS/pMMR Locally Advanced Rectal Cancer

Intraoperative Electron Radiotherapy in Rectal Cancer - A Feasibility Trial

Neoadjuvant Chemoradiotherapy Combined With PD-1 Inhibitor and Thymalfasin for pMMR/MSS Locally Advanced Mid-low Rectal Cancer