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

NCT04666090 | Active Not Recruiting Phase 2

• 1 other identifier: 2020-795
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Squamous Cell Carcinoma; Neoadjuvant Therapy

Keywords

Carrelizumab; Neoadjuvant Treatment; Esophageal Squamous Cell Carcinoma; Apatinib

Outcome Measures

Primary Outcomes (1)

• Pathological Complete Response (PCR)

  No residual invasive tumor cells were found in the pathological examination of resected specimens.

  1 month after surgery

Secondary Outcomes (7)

• Major Pathological Response (MPR)

  1 month after surgery

• Objective Response Rate (ORR)

  1 month after surgery

• 2-year and 5-year overall survival

  2-year and 5-year after surgery

• 2-year and 5-year disease-free survival

  2-year and 5-year after surgery

• Incidence of Treatment-related Adverse Events

  1 month after surgery

Study Arms (1)

Carillizumab

EXPERIMENTAL

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; Procedure: Esophagectomy; Other: Samples

Interventions

Carillizumab DRUG

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.

Also known as: Esophagectomy, Collecting samples from participant

Carillizumab

Esophagectomy PROCEDURE

Laparoscopy combined with thoracoscope radical resection of esophageal carcinoma

Carillizumab

Samples OTHER

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

Carillizumab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• with significant cardiovascular disease;
• current treatment with anti-viral therapy or HBV;
• Female patients who are pregnant or lactating;
• history of malignancy within 5 years prior to screening;
• active or history of autoimmune disease or immune deficiency;
• signs of distant metastases.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

2nd Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, China, 310009, China

Location

Related Publications (1)

• Wu Z, Wu C, Zhao J, Wu C, Peng H, Wang Q, Bai R, Fang X, He H, Shen H, Wu M. Camrelizumab, chemotherapy and apatinib in the neoadjuvant treatment of resectable oesophageal squamous cell carcinoma: a single-arm phase 2 trial. EClinicalMedicine. 2024 Apr 6;71:102579. doi: 10.1016/j.eclinm.2024.102579. eCollection 2024 May.

  PMID: 38618203 DERIVED

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

Esophagectomy; Sampling Studies

Condition Hierarchy (Ancestors)

Carcinoma, 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

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures; Surgical Procedures, Operative; Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Weilin Wang

  2nd Affiliated Hospital, School of Medicine, Zhejiang University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2020
• First Posted: December 14, 2020
• Study Start: November 23, 2020
• Primary Completion: December 31, 2022
• Study Completion (Estimated): November 1, 2030
• Last Updated: May 15, 2025

Record last verified: 2025-05

Locations

CN (1)