Combination of Pembrolizumab With Chemoradiation for Patients With Locally Advanced Esophageal Squamous Cell Carcinoma
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|ClinicalTrials.gov Identifier: NCT03792347|
Recruitment Status : Recruiting
First Posted : January 3, 2019
Last Update Posted : February 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Esophageal Squamous Cell Carcinoma||Drug: Pembrolizumab||Phase 1|
Esophageal cancer ranks the eighth most common cancer (the fifth most common cancer in China), while ESCC is the most common subtype in Asia (more than 90 % in china). Radical resection is thought to be the mainstay of esophageal cancer treatment and preoperative CRT is well applied in treating locally advanced esophageal cancer. In a multicohort, phase IB study, pembrolizumab was used in 23 unresectable esophageal cancer patients. In this clinical trial, the incidence of grade 3 treatment-related adverse events was 39 % without the appearance of grade 4 and higher-grade adverse event, while the overall response rate reached 30 %. The safety of immune checkpoint therapy for unresected esophageal cancers using nivolumab, a different PD-1 monoclonal antibody, has also been confirmed by high quality clinical trials.
This study will evaluate the safety and feasibility of preoperative immune checkpoint therapy using pembrolizumab 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||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|
|Masking:||None (Open Label)|
|Official Title:||A Phase Ib Study of Pre-Operative Pembrolizumab + Chemoradiation in Patients With Locally Advanced Esophageal Squamous Cell Carcinoma|
|Actual Study Start Date :||January 21, 2019|
|Estimated Primary Completion Date :||January 2024|
|Estimated Study Completion Date :||January 2024|
Experimental: Arm 1
Arm 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 15 and 29. Surgery will be performed within 6 weeks after completion of preoperative therapy described above.
Other Name: Keytruda
- Safety(The rates of grade 3 and higher-grade treatment-related adverse events) [ Time Frame: From date of treatment allocation until surgery was applied during study period or up to at least 90 days after last dose ]Incidence of adverse events using CTCAE 4.03;grade 3 treatment-related adverse events and higher-grade adverse event will be reported
- Feasibility (The rates of patients who finished pembrolizumab with chemoradiotherapy and receive surgery within 6 weeks after preoperative therapies.) [ Time Frame: From date of treatment allocation until surgery or definitive chemoradiotherapy was applied,whichever came first, assessed up to 5 months ]Feasibility was defined as completion of surgery within 6 weeks after preoperative therapies.
- Pathologic complete response [ Time Frame: From date of treatment allocation and during treatment period up to 1 year ]Pathologic complete response was defined as pT0N0M0
- Radiographic response [ Time Frame: From date of treatment allocation and during treatment period up to 3 months ]To assess radiographic response to neoadjuvant pembrolizumab with concurrent chemoradiotherapy using RECIST 1.1.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03792347
|Contact: Hecheng Li, PHD||00862164370045 ext email@example.com|
|Contact: Chengqiang Li||00862164370045 ext firstname.lastname@example.org|
|Ruijin Hospital, Shanghai JiaoTong University School of Medicine||Recruiting|
|Shanghai, Shanghai, China, 200025|
|Contact: Chengqiang Li, MD 00862164370045 ext 666112 email@example.com|
|Contact: Yuyan Zheng, MD 00862164370045 ext 666112 firstname.lastname@example.org|
|Principal Investigator:||Hecheng Li, MD PHD||Ruijin Hospital|