Camrelizumab Plus Neoadjuvant Chemotherapy or Chemoradiotherapy Versus Chemoradiotherapy in Resectable ESCC.

NCT05043688 | Recruiting Phase 3

• 1 other identifier: LS2160
• Study Type: interventional
• Target: 426
• Locations: 1 country
• Sites: 5

Brief Summary

The purpose of this study is to explore the effectiveness and safety of neoadjuvant immune combined chemotherapy or radiochemotherapy compared with traditional neoadjuvant radiochemotherapy in patients with locally advanced Esophageal Squamous Cell Carcinoma.

Conditions

Resectable Esophageal Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• EFS assessed by the investigator according to RECIST 1.1

  defined as event free survival,defined as the time from randomization to the occurrence of tumor progression/recurrence /death, whichever comes first

  median EFS approximately over 45 months

Secondary Outcomes (7)

• OS

  median OS approximately over 80 months

• R0 resection rate

  within 28 working days after surgery

• DFS

  median DFS approximately over 40 months

• HRQoL

  approximately 48 months

• pCR

  within 28 working days after surgery

Other Outcomes (1)

• biomarker testing

  approximately 48 months

Study Arms (3)

Neoadjuvant Chemotherapy With Camrelizumab

EXPERIMENTAL

Chemotherapy: Paclitaxel（Albumin Bound）100mg/m2, Day 1,8,15，Carboplatin AUC=5mg/ml/min, Day 1； Camrelizumab: Day 1, every 3 weeks, 2 cycles; Postoperative adjuvant treatment: Camrelizumab maintenance

Drug: Camrelizumab

Neoadjuvant Radiochemotherapy With Camrelizumab

EXPERIMENTAL

Chemotherapy: Paclitaxel 50mg/m2, Day 1,8,15,22,29，Carboplatin AUC=2mg/ml/min，Day 1,8,15,22,29 Camrelizumab: 200mg，Day 1,22 Radiotherapy: 41.4 Gy , D1-5/W Postoperative adjuvant treatment：Camrelizumab maintenance

Drug: Camrelizumab; Radiation: radiotherapy

Neoadjuvant Radiochemotherapy

ACTIVE COMPARATOR

Chemotherapy: Paclitaxel 50mg/m2, Day 1,8,15,22,29，Carboplatin AUC=2mg/ml/min，Day 1,8,15,22,29 Radiotherapy：41.4 Gy , D1-5/W. Postoperative adjuvant treatment: non-pCR: Camrelizumab maintenance; PCR: surveillance

Radiation: radiotherapy

Interventions

Camrelizumab DRUG

The study perform preoperative neoadjuvant therapy, surgery and postoperative adjuvant therapy on subjects. Preoperative neoadjuvant therapy includes 3 groups: iCamrelizumab combined with neoadjuvant chemotherapy; Camrelizumab combined with neoadjuvant radiochemotherapy, and neoadjuvant radiochemotherapy.

Neoadjuvant Chemotherapy With Camrelizumab; Neoadjuvant Radiochemotherapy With Camrelizumab

radiotherapy RADIATION

The study perform preoperative neoadjuvant therapy, surgery and postoperative adjuvant therapy on subjects. Preoperative neoadjuvant therapy includes 3 groups: iCamrelizumab combined with neoadjuvant chemotherapy; Camrelizumab combined with neoadjuvant radiochemotherapy, and neoadjuvant radiochemotherapy.

Neoadjuvant Radiochemotherapy; Neoadjuvant Radiochemotherapy With Camrelizumab

Eligibility Criteria

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

You may qualify if:

• The result of pathological biopsy showed esophageal squamous cell carcinoma;
• Have not received systemic or local treatment for esophageal cancer in the past;
• Age 18-75 years (including 18 and 75 years old), both male and female;
• ECOG score 0-1;
• Thoracic esophageal cancer assessed by CT/MRI/PET-CT etc. as resectable and the clinical stage is T1b-3N1-3M0 or T3N0M0, according to the 8th edition of AJCC staging;
• Those who are expected to achieve R0 resection;
• Voluntarily sign an informed consent form before treatment;
• Plan to receive surgical treatment after neoadjuvant treatment is completed;
• No surgical contraindications;
• Normal function of major organs
• Female subjects with fertility must undergo a serum pregnancy test within 72 hours before starting the study drug administration, and the result is negative, and take effective contraception during the trial and at least 3 months after the last administration Measures (such as intrauterine devices, contraceptives, or condoms); for male subjects whose partners are females of childbearing age, effective contraceptive measures should be taken during the trial and within 3 months after the last administration;
• The subjects have good compliance and can follow up the efficacy and adverse events/reactions according to the requirements of the plan;

You may not qualify if:

• There are unresectable factors, including unresectable tumors, unresectable contraindications for surgery, or rejection of surgery;
• Patients with supraclavicular lymph node metastasis;
• Poor nutritional status, BMI \<18.5 Kg/m2; if the symptomatic nutritional support is corrected before randomization, the main investigator can continue to consider it after evaluation;
• Those who are known to have a history of allergies to the drug components of this program;
• Have received or are receiving any of the following treatments in the past:
• Any radiotherapy, chemotherapy or other anti-tumor drugs for tumors;
• Immunosuppressive drugs or systemic hormone drugs are being used within 2 weeks before the first use of the study drug to achieve immunosuppressive purposes (dose\>10mg/day prednisone or equivalent dose); if there is no active autoimmune disease In the case of inhalation or topical use of steroids and prednisone doses\> 10 mg/day or equivalent doses of adrenal cortex hormone replacement are allowed;
• Received a live attenuated vaccine within 4 weeks before using the study drug for the first time;
• Have undergone major surgery or severe trauma within 4 weeks before using the study drug for the first time;
• A history of immunodeficiency, including a positive HIV test, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation or allogeneic bone marrow transplantation;
• There are clinical symptoms or diseases of the heart that are not well controlled;
• Severe infections (CTCAE v5.0\> level 2) occurred within 4 weeks before the first use of the study drug, such as severe pneumonia, bacteremia, infectious comorbidities that require hospitalization, etc.; baseline chest imaging examinations suggest activity Pulmonary inflammation, symptoms and signs of infection in the 14 days before the first use of the study drug, or those who require oral or intravenous antibiotic treatment, except for the prophylactic use of antibiotics;
• Participated in other drug clinical studies within 4 weeks before randomization;
• People who are currently accompanied by interstitial pneumonia or interstitial lung disease, or have a history of interstitial pneumonia or interstitial lung disease that requires hormone therapy, or have other pulmonary fibrosis that may interfere with the judgment and management of immune-related lung toxicity , Organizing pneumonia (such as bronchiolitis obliterans), pneumoconiosis, drug-related pneumonia, idiopathic pneumonia, or subjects whose CT shows active pneumonia or severe lung dysfunction during the screening period; active tuberculosis;
• Patients with any active autoimmune diseases or history of autoimmune diseases with the possibility of recurrence; patients with skin diseases that do not require systemic treatment, such as leukoplakia, psoriasis, hair loss, and insulin treatment Patients with controllable type I diabetes or a history of asthma, but who have been completely relieved during childhood without any intervention can be included in the group; patients with asthma who need bronchodilator intervention cannot be included in the group;

Sponsors & Collaborators

• Zhigang Li: lead
• Jiangsu HengRui Medicine Co., Ltd.: collaborator

Study Sites (5)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

Anyang Tumour Hospital

Anyang, China

RECRUITING

Sun yat-sen University Cancer Center

Guangzhou, China

RECRUITING

Anhui Provincial Hospital

Hefei, China

RECRUITING

Zhongshan Hospital of Fudan University

Shanghai, China

RECRUITING

Related Publications (1)

• Yang Y, Zhu L, Cheng Y, Liu Z, Cai X, Shao J, Zhang M, Liu J, Sun Y, Li Y, Yi J, Yu B, Jiang H, Chen H, Yang H, Tan L, Li Z. Three-arm phase II trial comparing camrelizumab plus chemotherapy versus camrelizumab plus chemoradiation versus chemoradiation as preoperative treatment for locally advanced esophageal squamous cell carcinoma (NICE-2 Study). BMC Cancer. 2022 May 6;22(1):506. doi: 10.1186/s12885-022-09573-6.

  PMID: 35524205 DERIVED

Related Links

• ClinicalTrials.gov Results Data Element Definitions for Interventional and Observational Studies (相关术语定义)
• Checklists, templates, and examples to help gather information needed to report results to ClinicalTrials.gov (试验结果填写指南)

MeSH Terms

Interventions

camrelizumab; Radiotherapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Yang Yang

  Shanghai Chest Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yang Yang

CONTACT

18930598090; yangyang321879@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: September 5, 2021
• First Posted: September 14, 2021
• Study Start: September 1, 2021
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2030
• Last Updated: October 17, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)