Carrelizumab Combined With Chemotherapy for Adjuvant Therapy of Esophageal Squamous Cell Carcinoma

NCT05637268 | Unknown Phase 2

• 1 other identifier: Peng Tang
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-arm, open, exploratory clinical study to evaluate the efficacy and safety of camrelizumab combined with chemotherapy for adjuvant treatment of nodal positive thoracic esophageal squamous cell carcinoma.

Conditions

Esophagus Cancer

Outcome Measures

Primary Outcomes (1)

• 3-year DFS rate

  The probability of 3-year disease-free survival

  8 weeks

Secondary Outcomes (3)

• DFS

  From date of randomization until the date of first documented progression, assessed up to 60 months

• 3 years OS rate

  8 weeks

• 5 years OS rate

  8 weeks

Study Arms (1)

treatment group

EXPERIMENTAL

Treatment with camrelizumab combined with chemotherapy was planned for 4 to 6 cycles, after which carrilizumab monotherapy was maintained until disease progression, unacceptable toxicity, or patient withdrawal. A total of 4 to 6 cycles, after carrilizumab maintenance treatment for one year.

Drug: Camrelizumab; Drug: Paclitaxel; Drug: Cisplatin

Interventions

Camrelizumab DRUG

Camrelizumab 200mg iv q2w

Also known as: Suzhou Shengdia Biological Medicine Co., LTD

treatment group

Paclitaxel DRUG

150mg/m² iv d1 q2w

treatment group

Cisplatin DRUG

50 mg/m² iv d2 q2w

treatment group

Eligibility Criteria

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

You may qualify if:

• Histologically confirmed thoracic esophageal squamous cell carcinoma (after R0 resection);
• Lymph node metastases without distant metastases (pM0);
• ECOG PS score: 0 \~ 1
• The enrolled patients were expected to tolerate the combination therapy and survive for more than 6 months.
• The functions of vital organs meet the following requirements (excluding the use of any blood components and cell growth factors within 14 days): - Neutrophils 1.5×10⁹/L - platelet count 100×10⁹ /L - hemoglobin 5.6 mmol/L (9g/dL); 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); - Upper limit of normal 1.5 times total bilirubin (TBIL) (ULN); - 2.5 times the upper limit of normal (ULN) for aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels; Urine protein \<2 +; If the urine protein is ≥2+, the 24-hour urine egg white quantification shows that the protein must be ≤1g
• Coagulation function is normal, no active bleeding and thrombotic disease
• Non-surgical sterilization or female patients of childbearing age who are required to use a medically approved contraceptive method (such as an IUD, birth control pill or condom) during the study treatment period and for 3 months after the study treatment period ends; Female patients of childbearing age who were not surgically sterilized must have a negative serum or urine HCG test within 7 days prior to study enrollment; And it must be non-lactation; Male patients with non-surgical sterilization or of childbearing age need to consent to use a medically approved contraceptive method with their spouse during the study treatment period and for 3 months after the study treatment period ends
• The subjects voluntarily participated in the study with good compliance and safety and survival follow-up

You may not qualify if:

• Previous radiotherapy, chemotherapy, concurrent chemoradiotherapy and immunotherapy or other targeted therapy;
• Imaging evidence of distant metastasis;
• Patients with esophageal squamous cell carcinoma after R1 or R2 resection;
• The subject has had or co-had other malignancies (except cured basal cell carcinoma of the skin and cervical carcinoma in situ);
• Patients who had received carrilizumab or other PD-1/PD-L1 treatment in the past could not be enrolled; The subject is known to have a prior allergy to macromolecular protein preparations, or is known to be allergic to any carrilizumab, purple or platinum components;
• Subject has any active autoimmune disease or history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis interstitial pneumonia, uveitis, enteritis, hepatitis, pituitaritis, vasculitis, nephritis, hyperthyroidism, hypothyroidism; Subjects with purpura or complete remission of childhood asthma without any intervention as adults could be included; Patients with asthma requiring medical intervention with bronchodilators were not included);
• Subjects who were taking immunosuppressant or systemic or absorbable topical hormone therapy for immunosuppressive purposes (dose \>10mg/ day prednisone or other therapeutic hormone) and continued to use it within 2 weeks prior to enrollment;
• Ascites or pleural effusion with clinical symptoms, requiring therapeutic puncture or drainage;
• Patients with poorly controlled cardiac clinical symptoms or diseases, such as :(1) heart failure of NYHA2 or above, (2) unstable angina pectoris, (3) myocardial infarction within 1 year, (4) clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention;
• Abnormal coagulation function (PT\>16s APTT\>43s TT\>21s Fbg\>2g/L), bleeding inclination or receiving thrombolytic or anticoagulant therapy;
• Subjects with active infection or unexplained fever \>38.5 degrees prior to initial administration during screening (subjects with tumor-related fever, as determined by the investigator, could be enrolled);
• Abdominal fistula and gastrointestinal perforation or abdominal abscess occurred less than 4 weeks before medication;
• Patients with previous or current objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia and severe impairment of lung function;
• Subjects are participating in other clinical studies or less than 1 month after the end of the previous clinical study; Subjects may receive other systemic antitumor therapies during the study;
• Live vaccine was administered less than 4 weeks before or possibly during the study period;

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Affiliated Cancer Hospital of Tianjin Medical University

Tianjin, Tianjin Municipality, 300000, China

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

camrelizumab; Long-Term Synaptic Depression; 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)

Neuronal Plasticity; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Peng Tang, archiater

  Affiliated Cancer Hospital of Tianjin Medical University

  STUDY CHAIR

Central Study Contacts

Peng M Tang, archiater

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: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: November 14, 2022
• First Posted: December 5, 2022
• Study Start: November 26, 2020
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2025
• Last Updated: December 5, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)