Cardenilimab Combined With Chemotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma

NCT06165380 | Recruiting Phase 2 DMC

• 1 other identifier: TJCC-EC001
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this trial is to test the efficacy and safety of cardenilimab combined with chemotherapy in the conversion therapy of locally advanced unresectable esophageal squamous cell carcinoma. type of study: clinical trial

Conditions

Esophageal Squamous Cell Carcinoma; Neoadjuvant Therapies

Keywords

Immunotherapy; Chemotherapy

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate

  The time from randomization to death from any cause.

  2-5 years

Secondary Outcomes (4)

• Pathologic Complete Response

  2-5 years

• Progression-Free-Survival

  2-5 years

• Overall survival

  2-5 years

• Safety

  2-5 years

Study Arms (1)

Cardenilimab Combined With Chemotherapy

EXPERIMENTAL

Drug: Cardenilimab Combined With Chemotherapy

Interventions

Cardenilimab Combined With Chemotherapy DRUG

Cardenilimab Combined With Chemotherapy

Cardenilimab Combined With Chemotherapy

Eligibility Criteria

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

You may qualify if:

• \. Sign written informed consent before implementing any trial-related procedures; 2. Male or female, age ≥18 years old; 3. Patients with histologically confirmed esophageal squamous cell carcinoma, diagnosed as cT4a, T4b, NXM0 according to the 8th edition of AJCC TNM staging, and assessed as initially unresectable by the surgeon; 4. Have not received any systemic treatment for the current disease in the past, including surgery, anti-tumor radiotherapy, chemotherapy/immunotherapy, etc.; 5. Patients who agree to undergo radical surgical treatment and are judged by the surgeon to have no contraindications to surgery 6. ECOG score 0-1 points; 7. Expected survival time \>6 months; 8. With sufficient organ function, subjects must meet the following laboratory indicators:
• Absolute neutrophil count (ANC) ≥1.5x109/L without using granulocyte colony-stimulating factor in the past 14 days;
• Without blood transfusion in the past 14 days, platelets ≥100×109/L;
• Hemoglobin \>9g/dL without blood transfusion or erythropoietin use in the past 14 days;
• Total bilirubin ≤1.5×upper limit of normal (ULN);
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) are within ≤2.5×ULN
• Serum creatinine ≤1.5×ULN and creatinine clearance (calculated using the Cockcroft-Gault formula) ≥60 ml/min;
• Good coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 times ULN;
• Euthyroid, defined as thyroid stimulating hormone (TSH) within the normal range. If baseline TSH is outside the normal range, subjects can also be enrolled if total T3 (or FT3) and FT4 are within the normal range;
• Myocardial enzyme spectrum is within the normal range (if the researcher comprehensively judges that simple laboratory abnormalities without clinical significance are also allowed to be included); 9. Female subjects of childbearing potential should receive a urine or serum pregnancy test with a negative result within 3 days before receiving the first dose of study drug (Day 1 of Cycle 1). If a urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is required. Women of non-reproductive age were defined as at least 1 year postmenopausal, or had undergone surgical sterilization or hysterectomy; 10. If there is a risk of pregnancy, all subjects (regardless of male or female) need to use low annual failure rate during the entire treatment period until 120 days after the last dose of study drug (or 180 days after the last dose of chemotherapy drug). Contraceptive measures at 1%.

You may not qualify if:

• Other malignant diseases diagnosed within 5 years before the first dose (excluding radical basal cell carcinoma of the skin, squamous epithelial carcinoma of the skin, and/or carcinoma in situ that has been radically resected);
• Endoscopically known signs of active bleeding in the lesion;
• Currently participating in interventional clinical research treatment, or have received other research drugs or used research equipment within 4 weeks before the first dose;
• Have previously received the following therapies: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or another type of stimulating or synergistic inhibition of T cell receptors (including but not limited to CTLA-4, OX-40, CD137 etc.) drugs;
• Have received systemic systemic treatment with Chinese patent medicines with anti-tumor indications or drugs with immunomodulatory effects (including thymosin, interferon, interleukin, except for local use to control pleural effusion) within 2 weeks before the first dose;
• Active autoimmune disease that requires systemic treatment (such as the use of disease-modifying drugs, glucocorticoids, or immunosuppressants) has occurred within 2 years before the first dose. Replacement therapies (such as thyroxine, insulin, or physiological glucocorticoids for adrenal or pituitary insufficiency, etc.) are not considered systemic treatments;
• Are receiving systemic glucocorticoid treatment (excluding nasal spray, inhaled or other local glucocorticoids) or any other form of immunosuppressive therapy within 7 days before the first dose of the study; Note: Physiological doses of glucocorticoids (≤10 mg/day of prednisone or equivalent) are allowed;
• Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation;
• People who are known to be allergic to the drugs used in this study;
• Those with multiple factors that affect capecitabine (such as inability to swallow, intestinal obstruction, etc.);
• Have not fully recovered from toxicity and/or complications caused by any intervention before initiating treatment (i.e., ≤Grade 1 or reaching baseline, excluding fatigue or alopecia);
• Known history of human immunodeficiency virus (HIV) infection (i.e. HIV 1/2 antibody positive);
• Untreated active hepatitis B (defined as HBsAg positivity and a detected HBV-DNA copy number greater than the upper limit of normal value in the laboratory of the research center);
• Note: Hepatitis B subjects who meet the following criteria can also be enrolled:
• The HBV viral load before the first dose is \<2500 copies/ml (500 IU/ml), and the subject should receive anti-HBV treatment during the entire study chemotherapy drug treatment period to avoid viral reactivation.

Sponsors & Collaborators

• Li Zhang: lead

Study Sites (1)

Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

RECRUITING

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Li Zhang

CONTACT

+86(027)83663407; luzigang@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 INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 1, 2023
• First Posted: December 11, 2023
• Study Start: October 23, 2023
• Primary Completion: August 31, 2025
• Study Completion: December 31, 2025
• Last Updated: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)