NCT04435197CompletedPhase 2
Pre-Operative Pembrolizumab + Chemoradiation in Patients With Locally Advanced Esophageal Squamous Cell Carcinoma
Multicenter Preoperative Anti-PD-1 Antibody Combined With Chemoradiotherapy for Locally Advanced Squamous Cell Carcinoma of Esophageus
Source: ClinicalTrials.gov · Last updated 3 Jul 2024
Brief summary (registry, in English)
To investigate the safety and activity of preoperative pembrolizumab combined with chemoradiotherapy for resectable esophageal squamous cell carcinoma (ESCC) ,20 patients enrolled in Phase Ib PALACE-1(NCT03792347).The results showed that preoperative pembrolizumab with concurrent chemoradiotherapy was safe, did not delay surgery and induced a pCR in 55.6% of resected tumors. In this multicentre prospective study(PALACE-2),the investigators will evaluate the efficacy of preoperative pembrolizumab with concurrent chemoradiotherapy in patients with locally advanced esophageal squamous cell carcinoma.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 143 (actual)
- First submitted
- 14 Jun 2020
- Start date
- 11 Aug 2020
- Primary completion date
- 30 Jun 2024
- Lead sponsor
- Ruijin Hospital
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT04435197
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 143
- From 11 Aug 2020 to the primary completion date, 30 Jun 2024
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who have a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications.
- Patient has received prior chemotherapy, radiotherapy, target therapy and immune therapy for this malignancy or for any other past malignancy.
Other illness
- Patients with active autoimmune disease or history of autoimmune disease.
- Subjects with a history of symptomatic interstitial lung disease.
- History of allergy to study drug components.
- 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
Other
- Women must not be pregnant or breast-feeding.
- Men with female partners (WOCBP) that are not willing to use contraception.
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ruijin Hospital, Shanghai Jiao Tong University School of Medicine Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Ruijin Hospital Shanghai Jiaotong University School of Medicine Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
Related publications
- Association between radiation dose to pulmonary vein substructures and post-treatment atrial fibrillation following neoadjuvant chemoradiotherapy for esophageal squamous cell cancer.Radiother Oncol · 2026 · PMID 41667012
- Preoperative pembrolizumab (anti-PD-1 antibody) combined with chemoradiotherapy for esophageal squamous cell carcinoma: a phase 1/2 trial (PALACE-2).Signal Transduct Target Ther · 2025 · PMID 41309527
This page is information, not medical advice. Discuss any trial with your doctor.