Camrelizumab Plus Neoadjuvant Chemotherapy or Chemoradiotherapy Versus Neoadjuvant Chemoradiotherapy Alone for Resectable Locally Advanced Esophageal Squamous Cell Carcinoma (NICE 2): a Multi-center, Randomized Phase II Trial

Who is this study for? Patients with locally advanced resectable esophageal squamous cell carcinoma
What treatments are being studied? SHR-1210
Status: Recruiting
Location: See all (5) locations...
Intervention Type: Radiation, Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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;

Locations
Other Locations
China
Anyang Tumour Hospital
RECRUITING
Anyang
Sun yat-sen University Cancer Center
RECRUITING
Guangzhou
Anhui Provincial Hospital
RECRUITING
Hefei
Shanghai Chest Hospital
RECRUITING
Shanghai
Zhongshan Hospital of Fudan University
RECRUITING
Shanghai
Contact Information
Primary
Yang Yang
yangyang321879@163.com
18930598090
Time Frame
Start Date: 2021-09-01
Estimated Completion Date: 2030-12-31
Participants
Target number of participants: 426
Treatments
Experimental: Neoadjuvant Chemotherapy With Camrelizumab
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
Experimental: Neoadjuvant Radiochemotherapy With Camrelizumab
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
Active_comparator: Neoadjuvant Radiochemotherapy
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
Related Therapeutic Areas
Sponsors
Collaborators: Jiangsu HengRui Medicine Co., Ltd.
Leads: Zhigang Li

This content was sourced from clinicaltrials.gov

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