Clinical trial · Observational
A Real-World Study of Immune Checkpoint Inhibitors and Chemotherapy for Advanced Esophageal Cancer
A Real-World Study Evaluating the Effectiveness and Safety of Immune Checkpoint Inhibitors and Chemotherapy for Advanced Esophageal 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)
The role of preoperative chemotherapy as standard therapy is well-established for advanced esophageal cancer. Immunotherapeutic agents such as Immune checkpoint inhibitors has been shown to improve objective response rate in solid tumors. However, there is a paucity of data regarding the efficacy and safety of preoperative immunotherapy plus chemotherapy in esophageal cancer patients in real-world practice. This study set out to investigate whether the combination of preoperative chemotherapy and immune checkpoint inhibitors is beneficial to improve the objective response rate as well as the pathological complete response rate in a real-world scenario.
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 Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Objective Response Rate (ORR)
- timeFrame
- Up to 24 weeks
- description
- Objective Response Rate
- measure
- Safety as measured by number of participants with Grade 3 and 4 adverse events
- timeFrame
- Up to 12 weeks
- description
- Number of Grade 3 and 4 adverse events as defined by CTCAE v5.0
- measure
- Feasibility of immunochemotherapy defined as at least 80% of the patients completed all planned courses
- timeFrame
- Up to 36 weeks
- description
- The feasibility of immunochemotherapy was defined as at least 80% of the patients completed all planned courses.
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologically diagnosed as esophageal squamous cell carcinoma * KPS≥80 * Adequate organ function * No distant metastasis * The diseases could be resected or potentially resectable after immunochemotherapy assessed by a thoracic oncologist Exclusion Criteria: * incomplete medical record which affects statistical analysis * have participated in previous interventional clinical trials * other situations evaluated by investigators not meet the enrollment
References
Publications (1)
- DERIVEDYang W, Ma SC, Fang Z, Liu Y, Zhang X, Wang F, Wang C, Wang Y, Wang X, Chen W, Luo H, Yang L, Zhang S, Zeng B, Liu Z, Ou Q, Cai J, Yeung SJ, Cheng C. TP53-centric ctDNA complements PET/CT for non-invasive assessment of pathological complete response and survival after neoadjuvant immunochemotherapy in esophageal squamous cell carcinoma: a prospective cohort study. Int J Surg. 2025 May 1;111(5):3256-3268. doi: 10.1097/JS9.0000000000002341. PMID 40146232