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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
Sponsor:
Information provided by (Responsible Party):
Hecheng Li M.D., Ph.D, Ruijin Hospital

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.

Condition or disease Intervention/treatment Phase
Esophageal Squamous Cell Carcinoma Drug: Pembrolizumab Phase 1

Detailed Description:

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.


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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)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Drug: Pembrolizumab
Arm1:Pre-operative Pembrolizumab+chemoradiotherapy
Other Name: Keytruda




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A patient will be eligible for inclusion in this study only if ALL of the following criteria apply:

    1. Histologically confirmed cT2-T4a,N0-N+,M0 resectable esophageal squamous cell carcinoma
    2. Eastern Cooperative Oncology Group (ECOG) performance status 0-1
    3. 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

Information from the National Library of Medicine

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


Contacts
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Contact: Hecheng Li, PHD 00862164370045 ext 00862164370045 hehcengli2000@hotmail.com
Contact: Chengqiang Li 00862164370045 ext 00862164370045 whipple@yeah.net

Locations
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China, Shanghai
Ruijin Hospital, Shanghai JiaoTong University School of Medicine Recruiting
Shanghai, Shanghai, China, 200025
Contact: Chengqiang Li, MD    00862164370045 ext 666112    whipple@yeah.net   
Contact: Yuyan Zheng, MD    00862164370045 ext 666112    yuyanzheng@outlook.com   
Sponsors and Collaborators
Hecheng Li M.D., Ph.D
Investigators
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Principal Investigator: Hecheng Li, MD PHD Ruijin Hospital

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Responsible Party: Hecheng Li M.D., Ph.D, Professor, Ruijin Hospital
ClinicalTrials.gov Identifier: NCT03792347     History of Changes
Other Study ID Numbers: RuijinH-nit
First Posted: January 3, 2019    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hecheng Li M.D., Ph.D, Ruijin Hospital:
esophageal squamous cell carcinoma
neoadjuvant chemoradiotherapy
pembrolizumab
immune therapy
checkpoint inhibitor

Additional relevant MeSH terms:
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Pembrolizumab
Carcinoma
Carcinoma, Squamous Cell
Esophageal Squamous Cell Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Antineoplastic Agents, Immunological
Antineoplastic Agents