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

ConditionResectable Esophageal Squamous Cell Carcinoma

Trial statusRecruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age18-75

SponsorZhigang Li

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

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.
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.

Treatment groups

426 Participants

are divided into 3 treatment groups

Group A: Neoadjuvant Chemotherapy With CamrelizumabExperimental treatment 1 intervention

Group B: Neoadjuvant Radiochemotherapy With CamrelizumabExperimental treatment 2 interventions

Group C: Neoadjuvant RadiochemotherapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

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

Time frame

median EFS approximately over 45 months

Secondary outcomes

defined as the time from registration to death due to any cause, or censored at date last known alive

Time frame

median OS approximately over 80 months

R0 resection rate

defined as complete surgery resection rate

Time frame

within 28 working days after surgery

DFS

defined as the time from the date of surgery who completed R0 resection to local or distant recurrence, or death due to any cause, whichever occurs first;

Time frame

median DFS approximately over 40 months

HRQoL

defined as quality and nutrition assessment

Time frame

approximately 48 months

Other outcomes

biomarker testing

explore the correlation between the expression of PD-L1 and outcomes

Time frame

approximately 48 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zhigang Li

Lead sponsor

Shanghai Chest Hospital

Sponsor institution

Jiangsu HengRui Medicine Co., Ltd.

Collaborator

Source ClinicalTrials.gov

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