Clinical trial · Interventional
Chemoradiotherapy Following Immunotherapy Plus Chemotherapy for Locally-advanced Esophageal Squamous Cell Cancer (RICE)
A Phase 2 Trial of Concurrent Chemoradiotherapy Following Immunotherapy Plus Chemotherapy for Patients With Locally-advanced Esophageal Squamous Cell Cancer
- 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 investigator-initiated, single-arm, exploratory clinical study.The study population consisted of non-operative Locally Advanced Esophageal Cancer . The purpose of this study was to evaluate the efficacy and safety of Concurrent Chemoradiotherapy Following Immunotherapy Plus Chemotherapy for Patients With Locally-advanced Esophageal Squamous Cell Cancer.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemotherapy | — | UNRESOLVED | — |
| Concurrent Chemoradiotherapy | — | UNRESOLVED | — |
| Esophageal Squamous Cell Carcinomas | Esophageal Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Immunotherapy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| chemotherapy combined with PD-1 inhibitors | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- experimental arm
- description
- Induction Therapy: Two cycles of induction chemotherapy (nab-paclitaxel 200 mg/m², day 1; carboplatin AUC 5, day 1) combined with a PD-1 inhibitor (200 mg, day 1) every 3 weeks. Concurrent Therapy: Followed by concurrent chemoradiotherapy (CCRT). Maintenance Therapy: Patients without progressive disease (PD) will receive maintenance immunotherapy with a PD-1 inhibitor (200 mg every 3 weeks) for up to 1 year.
- interventionNames
- Drug: chemotherapy combined with PD-1 inhibitors
Primary outcomes (1)
- measure
- Overall Survival Rate
- timeFrame
- 2 years after last patient enrolled
- description
- Overall survival rate is defined as the percentage of participants who are alive up to 2 years from enrollment
Secondary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Aged ≥ 18 years at the time of screening. 2. Histologically confirmed squamous cell carcinoma; 3. Locally-advanced ,medical inoperability, technical irresectability, or patient refusal to surgery; 4. Eastern Cooperative Oncology Group (ECOG) performance status:0-2; 5. Able to eat a semi-liquid diet; 6. Less than 20% weight loss within 6 months; 7. Adequate hepatic function, renal function, hematologic function and coagulation function; 8. Documented informed consent. Exclusion Criteria: 1. Distant metastasis; 2. Known malignancy diagnosed or require active treatment in the last 5 years, except for cancers that can be cured by surgery including cervical cancer in situ, basal or squamous cell skin cancer, breast ductal carcinoma in situ, localized prostate cancer; 3. Prior thoracic irradiation, chemotherapy, or lobectomy 4. Known diseases or conditions that are contraindicated for radiotherapy or surgery; 5. Allergy to the research medications; 6. Pregnant women or women preparing for pregnancy; 7. Diagnosis of autoimmune disease or history of chronic autoimmune disease 8. Absence of informed consent because of psychological, family, social and other factors; 9. Patients with comorbidities (chronic pulmonary disease, poorly controlled hypertension, unstable angina, myocardial infarction within 6 months, unstable mental disorders requiring therapy).
References
Publications (0)
Data not yet available