Clinical trial · Interventional
AK104 Plus Concurrent Chemoradiation Therapy in Esophageal Squamous Cell Carcinoma
The Preliminary Efficacy and Safety of AK104 Plus Concurrent Chemoradiation Therapy in Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma
NCT05594914CI-TRIAL-00061729unknownPhase 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)
The purpose of this study is to assess the safety and efficacy of AK104 plus concurrent chemoradiation therapy in unresectable locally advanced esophageal squamous cell carcinoma
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 |
|---|---|---|---|
| Esophageal Squamous Cell Carcinoma | Esophageal Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AK104 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- AK104 plus concurrent chemoradiation therapy
- description
- AK104 10mg/kg plus TC regimen(paclitaxel liposome 135mg/m2, carboplatin AUC=5), once every 3 weeks (Q3W), induction treatment for 2 cycles; Subsequently, AK104 10 mg/kg plus TC regimen(paclitaxel liposome 135mg/m2, carboplatin AUC=5) is combined with radiotherapy(50Gy/25F) for 2 cycles.
- interventionNames
- Drug: AK104
Primary outcomes (5)
- measure
- ORR
- timeFrame
- 24 months
- description
- objective response rate
- measure
- DCR
- timeFrame
- 24 months
- description
- disease control rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * unresectable locally advanced esophageal squamous cell carcinoma; ECOG PS 0-1; At least one measurable lesion according to RESIST standard 1.1； not received anti-tumor treatment in the past Exclusion Criteria: * received immunotherapy in the past； Active hepatitis B, hepatitis C and other infectious diseases； Severe liver and kidney function, cardiovascular and cerebrovascular abnormalities
References
Publications (0)
Data not yet available
No reference posted for this study.