Clinical trial · Interventional
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
NCT05980689CI-TRIAL-00073765unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced Rectal Cancer | Malignant Rectal Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AK104 | Drug | — | UNRESOLVED |
| Capecitabine | Drug | Capecitabine | ALIAS |
| Neoadjuvant Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment Arm
- description
- 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.
- interventionNames
- Drug: AK104
- Drug: Capecitabine
- Radiation: Neoadjuvant Radiotherapy
Primary outcomes (1)
- measure
- Complete response (CR) rate
- timeFrame
- an average of 6 months.
- description
- Rate of complete response (CR), including pathologic complete response (pCR) and clinical complete response (cCR).
Secondary outcomes (7)
- measure
- Adverse effects
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.