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Carrelizumab, Chemotherapy and Apatinib in the Neoadjuvant Treatment of Resectable Esophageal Squamous Cell Carcinoma

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ClinicalTrials.gov Identifier: NCT04666090
Recruitment Status : Recruiting
First Posted : December 14, 2020
Last Update Posted : December 14, 2020
Sponsor:
Information provided by (Responsible Party):
Second Affiliated Hospital, School of Medicine, Zhejiang University

Study Description
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Brief Summary:

China with high incidence of esophageal cancer, the number of new cases and deaths account for about 50% of the world every year. In the past few decades, surgery, radiotherapy, chemotherapy and other treatments were continuously improved, however, the mortality of esophageal squamous cell carcinoma patients was not significantly decreased.

For patients with locally advanced esophageal cancer, direct surgery is not effective. It is difficult to achieve radical resection by surgery merely, and even if many patients receive surgery, they may eventually have tumor recurrence and poor survival rate. Therefore, it is necessary to explore effective perioperative neoadjuvant treatment to reduce the risk of postoperative recurrence and improve the postoperative survival rate of patients.

According to the reports, the expression of PD-L1 in esophageal cancer was about 41.4%. Therefore, PD-1/ PD-L1 immunocheckpoint inhibitor may become a new method for the treatment of esophageal cancer. Preliminary clinical results showed that immunotherapy combined with chemoradiotherapy provided a synergies antitumor effect. Multiple clinical results showed that Carrillizumab provided higher overall response rate for advanced esophageal cancer.

However, in patients with locally advanced esophageal cancer, the efficacy of Carrillizumab combined with chemotherapy and apatinib for sequential radical surgery is still unclear. The purpose of this study is to observe and evaluate the efficacy and safety of Carrillizumab combined with chemotherapy and antiangiogenic drugs in the neoadjuvant therapy of resectable esophageal squamous cell carcinoma.


Condition or disease Intervention/treatment Phase
Esophageal Squamous Cell Carcinoma Neoadjuvant Therapy Drug: Carillizumab Procedure: Esophagectomy Other: Samples Phase 2

Detailed Description:

Esophageal cancer is a common malignant tumor of the digestive tract. Every year, there are about 400,000 new cases of esophageal cancer in the world and about 300,000 people dying of this disease. China with high incidence of esophageal cancer, the number of new cases and deaths account for about 50% of the world every year. In the past few decades, surgery, radiotherapy, chemotherapy and other treatments were continuously improved, however, the mortality of esophageal squamous cell carcinoma patients was not significantly decreased. Early local invasion, lymph node metastasis and distant metastasis are the main causes of poor prognosis for the patients with esophageal squamous cell carcinoma.

For patients with locally advanced esophageal cancer, direct surgery is not effective. It is difficult to achieve radical resection by surgery merely, and even if many patients receive surgery, they may eventually have tumor recurrence and poor survival rate. Therefore, it is necessary to explore effective perioperative neoadjuvant treatment to reduce the risk of postoperative recurrence and improve the postoperative survival rate of patients.

In recent years, PD-1 antibody is undoubtedly the most dazzling star in the field of tumor therapy. It shows excellent efficacy in of the different kind of tumors. According to the reports, the expression of PD-L1 in esophageal cancer was about 41.4% (Meta-analysis of 1350 Chinese and Japanese subjects showed that the over-expression of PD-L1 tended to decrease overall survival). Therefore, PD-1/ PD-L1 immunocheckpoint inhibitor may become a new method for the treatment of esophageal cancer. Preliminary clinical results showed that immunotherapy combined with chemoradiotherapy provided a synergies antitumor effect. Multiple clinical results showed that Carrillizumab provided higher overall response rate for advanced esophageal cancer. It also provided superior progression free survival and overall survival compared with Pembrolizuma and paclitaxel. 2020 Chinese Society Of Clinical Oncology esophagus cancer guidelines recommended Carrillizumab as the first level for squamous cell carcinomas.

However, in patients with locally advanced esophageal cancer, the efficacy of Carrillizumab combined with chemotherapy and apatinib for sequential radical surgery is still unclear. The purpose of this study is to observe and evaluate the efficacy and safety of Carrillizumab combined with chemotherapy and antiangiogenic drugs in the neoadjuvant therapy of resectable esophageal squamous cell carcinoma.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 38 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, One-arm, Single-center Clinical Study of Carrelizumab Combined With Chemotherapy and Antiangiogenic Drugs in the Neoadjuvant Treatment of Resectable Esophageal Squamous Cell Carcinoma
Actual Study Start Date : November 23, 2020
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : November 2028

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Carillizumab

Preoperative neoadjuvant therapy for 2-3 cycles. Radical surgery is performed 4-6 weeks after the last dose. Postoperative radiotherapy is determined according to the clinical situation and pathological stage of the patient.

Carillizumab can be maintained for a maximum of 1 year. During the study, patients were be followed until disease progression, withdrawal of informed consent, loss of follow-up, or death.

 Drug: Carillizumab
administration regimen: Carillizumab 200mg, IV, D1; Albumin paclitaxel 150mg/m2, D1; Nedaplatin 50 mg/m2, D1; Apatinib 250mg Po D2-4. Preoperative neoadjuvant therapy for 2-3 cycles, one cycle every 14 days.
Other Names:
  • Esophagectomy
  • Collecting samples from participant

Procedure: Esophagectomy
Laparoscopy combined with thoracoscope radical resection of esophageal carcinoma

Other: Samples
Blood, Tumour and Saliva will be Collected from participant. Fate of sample is Destruction after use


Outcome Measures
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Primary Outcome Measures :
  1. Major Pathological Response (MPR) [ Time Frame: 1 month after surgery ]
    In the pathological examination of resected specimens, the proportion of residual tumor cells was less than 10%.


Secondary Outcome Measures :
  1. Pathological Complete Response (PCR) [ Time Frame: 1 month after surgery ]
    No residual invasive tumor cells were found in the pathological examination of resected specimens.

  2. Objective Response Rate (ORR) [ Time Frame: 1 month after surgery ]
    The proportion of subjects with imaging PR or CR assessed according to RECIST 1.1 criteria

  3. 2-year and 5-year overall survival [ Time Frame: 2-year and 5-year after surgery ]
    The proportion of all study cases in which no death from any cause occurred within 2 years and 5 years after surgery

  4. 2-year and 5-year disease-free survival [ Time Frame: 2-year and 5-year after surgery ]
    No recurrence, distant metastasis, or death within 2 years and 5 years after surgery accounted for the proportion of all cases studied.

  5. Incidence of Treatment-related Adverse Events [ Time Frame: 1 month after surgery ]
    Incidence of Treatment-related Adverse Events as Assessed by CTCAE v5.0

  6. R0 resection rate [ Time Frame: 1 month after surgery ]
    The pathological results showed that the incision margin was negative and no residual cancer cells were found under the microscope


Eligibility Criteria
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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:

  1. signed informed consent;
  2. patients age 18 to 75 years old
  3. primary resectable, histologically confirmed esophageal squamous cell cancer;
  4. Esophageal squamous cell carcinoma the clinical stage was IIA-IVA (according to AJCC TNM stage, 8th edition).
  5. ECOG PS 0-1.
  6. No distant metastasis, the diseases could be resectable assessed by thoracic oncologist;

Exclusion Criteria:

  1. with significant cardiovascular disease;
  2. current treatment with anti-viral therapy or HBV;
  3. Female patients who are pregnant or lactating;
  4. history of malignancy within 5 years prior to screening;
  5. active or history of autoimmune disease or immune deficiency;
  6. signs of distant metastases.
Contacts and Locations
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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): NCT04666090


Contacts
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Contact: Ming Wu, M.D +8613757118715 iwuming22@zju.edu.cn

Locations
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China
2nd Affiliated Hospital, School of Medicine, Zhejiang University Recruiting
Hangzhou, China, 310009
Contact: Ming Wu, M.D    +8613757118715    iwuming22@zju.edu.cn   
Sponsors and Collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University
Investigators
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Study Chair: Weilin Wang 2nd Affiliated Hospital, School of Medicine, Zhejiang University
More Information
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Responsible Party: Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier: NCT04666090    
Other Study ID Numbers: 2020-795
First Posted: December 14, 2020    Key Record Dates
Last Update Posted: December 14, 2020
Last Verified: December 2020

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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 Second Affiliated Hospital, School of Medicine, Zhejiang University:
Carrelizumab
Neoadjuvant Treatment
Esophageal Squamous Cell Carcinoma
Apatinib
Additional relevant MeSH terms:
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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