Neoadjuvant Therapy of Camrelizumab Combined With Chemotherapy for Resectable Locally Advanced Esophageal Squamous Cell Carcinoma

NCT05476380 | Unknown Phase 2

• 1 other identifier: 21-OBU-TJ-BB-EC-II-00
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the efficacy and safety of neoadjuvant therapy of camrelizumab combined with chemotherapy for resectable locally advanced esophageal squamous cell carcinoma

Conditions

Esophageal Carcinoma

Keywords

Esophageal Carcinoma; Camrelizumab; Neoadjuvant therapy

Outcome Measures

Primary Outcomes (1)

• pCR

  pathological complete response rate

  within 28 working days after operation

Secondary Outcomes (4)

• 1year DFS rate

  Refers to the time from initiation to tumor recurrence or death from any cause (up to approximately 1 year)

• Postoperative complication rate

  within 28 working days after operation

• R0 resection rate

  within 28 working days after operation

• DFS

  Refers to the time from initiation to tumor recurrence or death from any cause (up to approximately 3 years)

Study Arms (1)

CCNT-ESCC

EXPERIMENTAL

This study is a single-arm, open-label, exploratory clinical study, the main purpose of which is to evaluate the efficacy and safety of neoadjuvant treatment of camrelizumab combined with chemotherapy for resectable locally advanced esophageal squamous cell carcinoma. After screening, subjects who meet the requirements for entry and exclusion signed the informed consent, received neoadjuvant treatment of carrelizumab combined with combined with chemotherapy.The patient will receive three cycles of treatment of camrelizumab(200 mg, IV., d1, q3w), paclitaxel(175 mg/m2,continuous IV., d1, 24h q3w), cisplatin(75 mg/m2, iv., d1,q3w).Patients who are assessed as being able to undergo surgical resection receive elective resection surgery,and the maintenance treatment of postoperative patients implements individualized treatment.

Drug: camrelizumab

Interventions

camrelizumab DRUG

Camrelizumab:200 mg, IV., d1, q3w; Paclitaxel:175 mg/m2,continuous IV., d1, 24h q3w; Cisplatin:75 mg/m2, iv., d1,q3w

Also known as: Paclitaxel, Cisplatin

CCNT-ESCC

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) Sign the written informed consent before joining the group;
• \) Age 18-70 years old, both male and female
• \) T3N+M0 patients with resectable esophageal squamous cell carcinoma confirmed by pathology and imaging（AJCC/UICC eighth edition TNM staging of esophageal cancer）
• \) Evaluation of patients with locally advanced surgical resection before treatment
• \) There are measurable lesions that meet the RECIST v1.1 criteria for evaluation;
• \) ECOG PS score: 0 to 1;
• \) The expected survival period is greater than 6 months;
• \) It is allowed to take blood samples and postoperative pathological sections;
• \) The function of vital organs meets the following requirements (excluding the use of any blood components and cell growth factors within 14 days):
• Blood routine:
• Neutrophil ≥1.5\*109/L
• Platelet count≥100\*109/L
• Hemoglobin ≥ 90g/L;
• Liver and kidney function:
• Serum creatinine (SCr) ≤ 1.5 times the upper limit of normal (ULN) or creatinine clearance ≥ 50 ml/min (Cockcroft-Gault formula);

You may not qualify if:

• \) Previously received radiotherapy, chemotherapy, hormone therapy, surgery or molecular targeted therapy;
• \) Patients with distant metastasis confirmed by imaging;
• \) The subject has suffered from other malignant tumors in the past or at the same time (except for cured skin basal cell carcinoma and cervical carcinoma in situ);
• \) Previous treatment with camrelizumab or other PD-1/PD-L1 therapy; known subjects had previous treatment with macromolecular protein preparations, or known treatment with any camrelizumab, paclitaxel or platinum Allergic to ingredients;
• \) The subject has any active autoimmune disease or has a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis , nephritis, hyperthyroidism, hypothyroidism; subjects with vitiligo or complete remission of asthma in childhood without any intervention in adulthood can be included; subjects with asthma requiring bronchodilator medical intervention are not included );
• \) The subject is using immunosuppressive, or systemic, or absorbable local hormone therapy to achieve the purpose of immunosuppression (dose \> 10mg/day prednisone or other equivalent hormones), and within 2 weeks before enrollment is still in use;
• \) Ascites or pleural effusion with clinical symptoms requires therapeutic puncture or drainage;
• \) There are clinical symptoms or diseases of the heart that cannot be well controlled, such as: (1) NYHA grade 2 or higher heart failure (2) unstable angina pectoris (3) myocardial infarction within 1 year (4) clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention;
• \) Abnormal coagulation function (PT\>16s, APTT\>43s, TT\>21s, Fbg\>2g/L), with bleeding tendency or receiving thrombolytic or anticoagulation therapy;
• \) The patient currently (within 3 months) has esophageal varices, active gastric and duodenal ulcers, ulcerative colitis, portal hypertension and other gastrointestinal diseases, or the unresectable tumor has active bleeding, or the investigator determines other conditions that may cause gastrointestinal bleeding and perforation;
• \) Past or current severe bleeding (bleeding \>30 ml within 3 months), hemoptysis (\>5 ml fresh blood within 4 weeks), or thromboembolic events (including stroke events and/or transient cerebral insufficiency) within 12 months blood attack);
• \) The subject has active infection or unexplained fever \>38.5 degrees during the screening period and before the first administration (subject to the investigator's judgment, the subject's fever due to tumor can be enrolled);
• \) Abdominal fistula, gastrointestinal perforation or abdominal abscess occurred less than 4 weeks before study medication;
• \) Patients with past and current objective evidence of a history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, severely impaired lung function, etc.;
• \) The subject is participating in other clinical studies or less than 1 month after the end of the previous clinical study; the subject may receive other systemic anti-tumor therapy during the study;

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Medical University Cancer Institute & Hospital

Tianjin, China

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

camrelizumab; Paclitaxel; Cisplatin

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Central Study Contacts

Peng Tang, MD

CONTACT

18526812877; 18526812877@163.com

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: July 25, 2022
• First Posted: July 27, 2022
• Study Start: February 19, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2024
• Last Updated: July 27, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)