Clinical Study on the Efficacy and Safety of Iparomlimab and Tuvonralimab Injection Combined With Nab-Paclitaxel in Neoadjuvant Therapy for Locally Advanced Resectable Esophageal Squamous Cell Carcinoma

Tianjin Medical University

Status and phase

Begins enrollment in 1 month

Phase 2

Conditions

ESCC

Treatments

Drug: lparomlimab and Tuvonralimab Injection in Combination with Nab-Paclitaxel

Study type

Interventional

Funder types

Other

Identifiers

NCT07493993

E20260292

Details and patient eligibility

About

Major objectives to evaluate the efficacy and safety of Iparomlimab and Tuvonralimab Injection (QL1706,an Anti-PD-1/CTLA-4 Combined Antibody) combined with Nab-Paclitaxel in neoadjuvant therapy for patients with locally advanced resectable esophageal squamous cell carcinoma.

Full description

This clinical study aims to evaluate the efficacy and safety of Iparomlimab and Tuvonralimab Injection (QL1706,an Anti-PD-1/CTLA-4 Combined Antibody) combined with Nab-Paclitaxel in neoadjuvant therapy for patients with locally advanced resectable esophageal squamous cell carcinoma.This study consists of three phases: screening, treatment, and follow-up.Efficacy evaluation and safety monitoring should be performed throughout the study.

Enrollment

26 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Voluntarily understand and sign the informed consent form for this study.
Age ≥ 18 years, male or female.
Histologically or cytologically confirmed thoracic ESCC (Stage T1-2N1-2M0 or T3N0-2M0, according to the AJCC 8th edition).
ECOG performance status of 0-2.
No prior treatment for esophageal squamous cell carcinoma.
Life expectancy ≥ 3 months.
Adequate function of major organs within 7 days before the first treatment (use of any blood components or cell growth factors within 14 days before enrollment is not permitted):Hemoglobin ≥ 90 g/L; White blood cell count ≥ 3.5 × 10^9/L; Absolute neutrophil count ≥ 1.5 × 10^9/L; Platelets ≥ 80 × 10^9/L; AST and ALT ≤ 2.5 × ULN; Total bilirubin (TBIL) ≤ 1.5 × ULN; Blood urea nitrogen (BUN) and creatinine (Cr) ≤ 1.5 × ULN (and creatinine clearance (CCr) ≥ 50 mL/min); Left ventricular ejection fraction (LVEF) ≥ 50%.
Fertile patients must agree to use reliable contraceptive methods with their partner during the trial and for at least 180 days after the last dose.

Exclusion criteria

Inability to comply with the study protocol or study procedures.
Presence of supraclavicular lymph node metastasis.
Obvious tumor invasion of organs adjacent to the esophageal lesion.
Evidence of esophagomediastinal or tracheoesophageal fistula found on imaging within 4 weeks before enrollment.
Allergy or known hypersensitivity to the study drugs or their excipients.
Anticipated need for systemic corticosteroids or other immunosuppressive therapy during the study treatment period.
Active autoimmune disease requiring systemic treatment, or a history of autoimmune disease.
Positive HIV test; positive hepatitis B surface antigen with HBV-DNA > upper limit of normal; active hepatitis C virus (HCV) infection.
History of esophageal or gastric variceal bleeding due to portal hypertension within 6 months before the first study drug administration; known severe varices on endoscopy within 3 months before the first study drug administration.
Current interstitial pneumonia or interstitial lung disease, or a history of interstitial pneumonia or interstitial lung disease requiring steroid therapy, or other pulmonary fibrosis, organizing pneumonia that might interfere with the assessment and management of immune-related pulmonary toxicity.
Evidence of a significant bleeding tendency or other major coagulation disorders.
Severe cardiovascular or cerebrovascular disease.
Other malignancies within 5 years before enrollment, except for radically resected basal cell or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix.
History of allogeneic bone marrow transplantation or organ transplantation.
Patients considered by the investigator to be unsuitable for participation in this study.