Clinical trial · Interventional
Induction Chemo-Immunotherapy + Radiotherapy vs Concurrent Chemoradiotherapy for Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma
Efficacy and Safety of Induction Chemo-Immunotherapy Followed by Radiotherapy vs Concurrent Chemoradiotherapy in Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma: A Randomized, Two-Arm, Phase II Study
- 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 a prospective, randomized, phase II clinical study in patients with unresectable stage III-IVA esophageal squamous cell carcinoma (ESCC). Eligible patients will be randomly assigned in a 1:1 ratio to two treatment groups. The experimental group will receive 3 cycles of induction therapy with PD-1 antibody plus chemotherapy, followed by radiotherapy, and then maintenance therapy with PD-1 antibody monotherapy. The control group will receive concurrent chemoradiotherapy, followed by maintenance therapy with PD-1 antibody monotherapy. The primary endpoints are the complete response (CR) rate at 3 months after radiotherapy (assessed by investigators) and the 1-year progression-free survival (PFS) rate. Secondary endpoints include overall survival (OS), progression-free survival (PFS), duration of response, objective response rate (ORR), local-regional recurrence-free survival (LRFS), distant metastasis-free survival (DMFS), quality of life, and safety profile.
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 (ESCC) | Esophageal Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Paclitaxel plus Cisplatin or Carboplatin (Induction Chemotherapy) | Drug | — | UNRESOLVED |
| Weekly Paclitaxel plus Cisplatin or Carboplatin (Concurrent Chemotherapy) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental Group: Chemo-Immunotherapy Induction + Radiotherapy + PD-1 Maintenance
- description
- Patients receive 3 cycles of PD-1 antibody plus chemotherapy induction therapy, followed by thoracic radiotherapy (50.4Gy in 28 fractions), then PD-1 antibody maintenance therapy (200mg IV q3w, up to 1 year).
- interventionNames
- Drug: Paclitaxel plus Cisplatin or Carboplatin (Induction Chemotherapy)
- type
- ACTIVE_COMPARATOR
- label
- Control Group: Concurrent Chemoradiotherapy + PD-1 Maintenance
- description
- Patients receive weekly paclitaxel + cisplatin/carboplatin concurrent with thoracic radiotherapy (50.4Gy in 28 fractions), then PD-1 antibody maintenance therapy (200mg IV q3w, up to 1 year).
- interventionNames
- Drug: Weekly Paclitaxel plus Cisplatin or Carboplatin (Concurrent Chemotherapy)
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed unresectable stage III-IVA esophageal squamous cell carcinoma (ESCC) * Eastern Cooperative Oncology Group (ECOG) performance status 0-1 * Adequate organ function (bone marrow, liver, renal, cardiac) within 2 weeks prior to randomization * Measurable or evaluable disease per RECIST 1.1 * Willing to provide written informed consent Exclusion Criteria: * Previous radiotherapy to the chest or previous systemic chemotherapy for ESCC * History of other malignancies within the last 5 years (except cured basal cell carcinoma or cervical carcinoma in situ) * Severe comorbidities (uncontrolled hypertension, NYHA class III-IV heart failure, active infection, etc.) * Known hypersensitivity to any study drugs (paclitaxel, cisplatin/carboplatin, PD-1 antibody) * Pregnant or lactating women * Participation in another clinical trial within 30 days prior to randomization
References
Publications (0)
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