Phase 1
Completed N=20
Preoperative Anti-PD-1 Antibody Combined With Chemoradiotherapy for Locally Advanced Squamous Cell Carcinoma of Esophagus
Source: ClinicalTrials.gov NCT03792347 ↗Enrolled (actual)
20
Serious AEs
65.0%
Results posted
Nov 2023
Primary outcomePrimary: Safety (Number of Participants With Grade 3 and Higher-grade Treatment-related Adverse Events) — 13 Participants
Summary
This study will evaluate the safety and feasibility of preoperative immune checkpoint therapy with concurrent chemoradiotherapy in patients with locally advanced esophageal squamous cell carcinoma. And this study will provide valuable information for further clinical trials of preoperative pembrolizumab and other immune checkpoint therapy in esophageal cancer treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety (Number of Participants With Grade 3 and Higher-grade Treatment-related Adverse Events) |
13 | — |
| SECONDARY Feasibility (Number of Participants Who Finished Pembrolizumab With Chemoradiotherapy and Receive Surgery Within 4-6 Weeks After Preoperative Therapies) |
11 | — |
| SECONDARY Pathologic Complete Response |
10 | — |
| SECONDARY Radiographic Response |
6 | — |
Eligibility Criteria
Inclusion Criteria
- A patient will be eligible for inclusion in this study only if ALL of the following criteria apply:
- Histologically confirmed cT2-T4a, N0-N+,M0 resectable esophageal squamous cell carcinoma
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Patients approve and sign the informed consent
Exclusion Criteria
- 1. Patients with active autoimmune disease or history of autoimmune disease 2. Patients who have a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications 3. Subjects with a history of symptomatic interstitial lung disease 4. History of allergy to study drug components 5. Women must not be pregnant or breast-feeding 6. Men with female partners (WOCBP) that are not willing to use contraception 7. Patient has received prior chemotherapy, radiotherapy, target therapy and immune therapy for this malignancy or for any other past malignancy 8. Underlying medical conditions that, in the Investigator's opinion, will make the administration of study drug hazardous or obscure the interpretation of toxicity or adverse events
Data sourced from ClinicalTrials.gov (NCT03792347). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.