Neoadjuvant Cardonilizumab Combined With Neoadjuvant Chemoradiotherapy Can Resect Locally Advanced Esophageal Squamous Cell Carcinoma

NCT07699185 | Recruiting Phase 2

• 1 other identifier: 2024TJCR007
• Study Type: interventional
• Target: 336
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multicenter, open-label, randomized, controlled clinical study to compare the efficacy and safety of cardonilizumab combined with neoadjuvant chemotherapy and surgery versus neoadjuvant chemoradiotherapy and surgery in locally advanced ESCC. Subjects were randomly divided into experimental group and control group, the experimental group received neoadjuvant immunotherapy concurrent chemotherapy regimen, the control group received neoadjuvant concurrent chemoradiotherapy regimen, and then received McKeown surgery. The primary outcome measures were complete pathological response (pCR), and the secondary outcome measures were major pathological response (MPR), EFS (event-free survival), OS (overall survival), overall response rate (ORR), decreased pathological stage, R0 resection rate, adverse events (AE), and perioperative complications

Conditions

Esophageal Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Pathologic Complete Response Rate

  Percentage of participants with pathologic complete response, defined as no viable tumor cells in all resected tumor specimens and sampled regional lymph nodes after neoadjuvant treatment.

  At surgery, after completion of neoadjuvant treatment

Secondary Outcomes (8)

• Major Pathologic Response Rate

  At the time of pathological assessment after surgery

• Event-Free Survival

  From randomization up to 5 years

• Overall Survival

  From randomization up to 5 years

• Objective Response Rate Assessed by RECIST v1.1

  From baseline to preoperative tumor assessment after neoadjuvant treatment

• Pathologic Downstaging Rate Based on TNM Staging

  At the time of pathological assessment after surgery

Study Arms (2)

Cardonilizumab+Paclitaxel+Cisplatin+ Surgery（168）

EXPERIMENTAL

Cardonilizumab 10 mg/kg, once every 3 weeks, will be administered intravenously as an infusion of 120 minutes (±10 minutes). The investigator continuously monitors potential infusion responses and pretreats hypersensitivity reactions and/or adjusts the infusion rate as recommended by the protocol. For subjects who cannot tolerate a 120-minute infusion, the infusion time can be extended to a maximum of 240 minutes. Within 72 hours prior to each dosing, subjects were required to complete a series of tests including vital signs, physical examination, laboratory tests, and fitness status scores to assess the safety and tolerability of continued treatment Paclitaxel 135mg/m2, intravenous infusion on the second day, once /3 weeks, 3 consecutive cycles before surgery; Cisplatin 80mg/m2, intravenous infusion on day 2, once /3 weeks, 3 consecutive cycles before surgery Surgery: McKeown esophagectomy Interventions: Biological: Cardonilizumab Drug: Paclitaxel Drug: Paclitaxel

Biological: Cardonilizumab; Drug: Paclitaxel; Drug: Cisplatin

neoadjuvant chemoradiotherapy+ Surgery（168）

EXPERIMENTAL

Radiotherapy: 40 Gy (2Gy×20 times), 5 times/week for 5 consecutive weeks; Chemotherapy: paclitaxel 50mg/m2+ cisplatin 25mg/m2 once a week for 4 weeks. The control group was followed up after R0 resection or adjusted according to the guidelines Surgery: McKeown esophagectomy Interventions: Radiation: neoadjuvant chemoradiotherapy

Radiation: neoadjuvant chemoradiotherapy

Interventions

Cardonilizumab BIOLOGICAL

Cardonilizumab 10 mg/kg, once every 3 weeks, will be administered intravenously as an infusion of 120 minutes (±10 minutes). The investigator continuously monitors potential infusion responses and pretreats hypersensitivity reactions and/or adjusts the infusion rate as recommended by the protocol. For subjects who cannot tolerate a 120-minute infusion, the infusion time can be extended to a maximum of 240 minutes. Within 72 hours prior to each dosing, subjects were required to complete a series of tests including vital signs, physical examination, laboratory tests, and fitness status scores to assess the safety and tolerability of continued treatment

Cardonilizumab+Paclitaxel+Cisplatin+ Surgery（168）

Paclitaxel DRUG

paclitaxel 135mg/m2, intravenous infusion on day 2, once /3 weeks, 3 consecutive cycles before surgery

Cardonilizumab+Paclitaxel+Cisplatin+ Surgery（168）

Cisplatin DRUG

Cisplatin 80mg/m2, intravenous infusion on day 2, once /3 weeks, 3 consecutive cycles before surgery

Cardonilizumab+Paclitaxel+Cisplatin+ Surgery（168）

neoadjuvant chemoradiotherapy RADIATION

Radiotherapy: 40 Gy (2Gy×20 times), 5 times/week for 5 consecutive weeks; Chemotherapy: paclitaxel 50mg/m2+ cisplatin 25mg/m2 once a week for 4 weeks

neoadjuvant chemoradiotherapy+ Surgery（168）

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sign a written informed consent before implementing any procedures related to the trial;
• Male or female, 18 years old ≤75 years old;
• Patients with histologically proven ESCC with a pathological stage of cT1N2M0 or cT2-3N0-2M0 according to AJCC Version 8 TNM stage and eligible for R0 surgical resection prior to treatment;
• Have not received systematic treatment for the current disease, including surgical treatment, anti-tumor chemoradiotherapy/immunotherapy, etc.;
• Patients who agree to radical surgical treatment and are judged by the surgeon to have no surgical contraindications;
• ECOG score 0-1;
• Expected survival time \>6 months;
• For adequate organ function, subjects must meet the following laboratory criteria:
• For adequate organ function, subjects must meet the following laboratory criteria:
• The absolute value of neutrophil (ANC) ≥1.5x109/L in the past 14 days without the use of granulocyte colony-stimulating factor;
• Platelets ≥100×109/L without blood transfusion in the past 14 days;
• Hemoglobin \>9g/dL in the last 14 days without blood transfusion or use of erythropoietin;
• Total bilirubin ≤1.5× upper limit of normal (ULN);
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) are ≤2.5×ULN
• Serum creatinine ≤1.5×ULN and creatinine clearance (calculated by Cockcroft-Gault formula) ≥60 ml/min;

You may not qualify if:

• Diagnosis of other malignant diseases (excluding radical basal cell carcinoma of the skin, squamous epithelial carcinoma of the skin, and/or carcinoma in situ after radical resection) within 1.5 years;
• Known endoscopic signs of active bleeding;
• Is currently participating in an interventional clinical study, or has received other investigational drugs or used investigational devices within 4 weeks prior to initial dosing;
• Previous treatment with anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or drugs that respond to another stimulus or synergistic inhibition of T cell receptors (including but not limited to CTLA-4, OX-40, CD137, etc.);
• Received systemic systemic treatment with Chinese patent drugs with anti-tumor indications or immunomodulatory drugs (including thymosin, interferon, interleukin, except for local use to control pleural fluid) within 2 weeks before the first administration;
• An active autoimmune disease requiring systemic treatment (e.g. with disease-modifying drugs, glucocorticoids, or immunosuppressants) has occurred within 2 years prior to first administration. Replacement therapies (such as thyroxine, insulin, or physiologic glucocorticoids for adrenal or pituitary insufficiency) are not considered systemic therapy;
• Was receiving systemic glucocorticoid therapy (excluding topical glucocorticoids by nasal spray, inhalation, or other route) or any other form of immunosuppressive therapy within 7 days prior to the study's initial administration; Note: The use of physiological doses of glucocorticoids (≤10 mg/ day of prednisone or equivalent) is permitted;
• Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation;
• Known allergy to the drugs used in this study;
• Has not fully recovered from toxicity and/or complications caused by any intervention before starting treatment (i.e., ≤ grade 1 or baseline, excluding weakness or hair loss);
• Known history of human immunodeficiency virus (HIV) infection (i.e. HIV 1/2 antibody positive);
• Untreated active hepatitis B (defined as HBsAg positive and HBV-DNA copy number detected greater than the upper limit of normal value in the laboratory of the study center); Note: Hepatitis B subjects who meet the following criteria can also be enrolled:
• HBV viral load \<2500 copies /ml (500 IU/ml) prior to initial dosing, subjects should receive anti-HBV therapy throughout study chemotherapy therapy to avoid viral reactivation
• For subjects with anti-HBC (+), HBsAg (-), anti-HBS (-) and HBV viral load (-), prophylactic anti-HBV therapy is not required, but close monitoring of viral reactivation is required
• Active HCV-infected subjects (HCV antibody positive and HCV-RNA levels above the lower limit of detection);

Sponsors & Collaborators

• Tongji Hospital: lead

Study Sites (1)

Tongji hospital

Wuhan, Hubei, 430030, China

RECRUITING

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

Paclitaxel; Cisplatin; Neoadjuvant 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)

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

Central Study Contacts

Ni Zhang

CONTACT

13871288490; zhangnidoc@vip.163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: December 22, 2024
• First Posted: July 13, 2026
• Study Start: January 29, 2024
• Primary Completion: July 1, 2026
• Study Completion: July 1, 2026
• Last Updated: July 13, 2026

Record last verified: 2026-07

Locations

CN (1)