Preoperative Anti-PD-1 Antibody Combined With Chemoradiotherapy for Locally Advanced Squamous Cell Carcinoma of Esophagus
PALACE-1
A Phase Ib Study of Pre-Operative Pembrolizumab + Chemoradiation in Patients With Locally Advanced Esophageal Squamous Cell Carcinoma
1 other identifier
interventional
20
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jan 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 28, 2018
CompletedFirst Posted
Study publicly available on registry
January 3, 2019
CompletedStudy Start
First participant enrolled
January 21, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 17, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 17, 2020
CompletedResults Posted
Study results publicly available
November 22, 2023
CompletedNovember 22, 2023
November 1, 2023
1.2 years
December 28, 2018
August 10, 2020
November 20, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety (Number of Participants With Grade 3 and Higher-grade Treatment-related Adverse Events)
The number of participants with grade 3 and higher-grade treatment-related adverse events. Adverse events were evaluated using CTCAE 4.0, grade 3 treatment-related adverse events and higher-grade adverse events were reported.
From date of treatment allocation until surgery was applied during study period or up to at least 90 days after last dose
Secondary Outcomes (3)
Feasibility (Number of Participants Who Finished Pembrolizumab With Chemoradiotherapy and Receive Surgery Within 4-6 Weeks After Preoperative Therapies)
From date of treatment allocation until surgery or definitive chemoradiotherapy was applied, whichever came first, assessed up to 5 months
Pathologic Complete Response
Two weeks after surgery
Radiographic Response
From date of treatment allocation and during treatment period up to 3 months
Study Arms (1)
Arm 1
EXPERIMENTALArm 1:preoperative pembrolizumab with chemoradiotherapy group Participants will receive carboplatin (AUC=2) IV and paclitaxel (50mg/m²) IV on day 1,8,15,22,29. And radiotherapy will start on day 1 of chemotherapy. A total of 41.4 Gy, 23 fractions of 1.8 Gy, 5 fractions a week. Participants will also receive pembrolizumab (2mg/kg) IV on days 1 and 22. Surgery will be performed within 6 weeks after completion of preoperative therapy described above.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- \. 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ruijin Hospital, Shanghai JiaoTong University School of Medicine
Shanghai, Shanghai Municipality, 200025, China
Related Publications (1)
Li C, Zhao S, Zheng Y, Han Y, Chen X, Cheng Z, Wu Y, Feng X, Qi W, Chen K, Xiang J, Li J, Lerut T, Li H. Preoperative pembrolizumab combined with chemoradiotherapy for oesophageal squamous cell carcinoma (PALACE-1). Eur J Cancer. 2021 Feb;144:232-241. doi: 10.1016/j.ejca.2020.11.039. Epub 2020 Dec 26.
PMID: 33373868DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
This was a single arm study. The sample size was small. Patients were highly selected and from a single center. These may strict the generalizability of the results.
Results Point of Contact
- Title
- Prof. Hecheng Li, Chair of Thoracic Surgery
- Organization
- Ruijin Hospital, Shanghai JiaoTong University School of Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Hecheng Li, MD PHD
Ruijin Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
December 28, 2018
First Posted
January 3, 2019
Study Start
January 21, 2019
Primary Completion
March 17, 2020
Study Completion
June 17, 2020
Last Updated
November 22, 2023
Results First Posted
November 22, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will not share