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

NCT07493993 | Not Yet Recruiting Phase 2

• 1 other identifier: E20260292
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

ESCC

Keywords

Iparomlimab and Tuvonralimab Injection; Nab-Paclitaxel; neoadjuvant therapy; ESCC

Outcome Measures

Primary Outcomes (1)

• Pathologic complete response rate (pCR)

  refers to the absence of viable tumor cells in both the primary tumor bed and the regional lymph nodes in the surgically resected specimens.

  up to 6 month

Secondary Outcomes (6)

• Major Pathologic Response rate (MPR)

  up to 12 month

• R0 Resection rate

  up to 12 month

• Event-Free Survival (EFS)

  up to 12 month

• Disease-Free Survival (DFS)

  up to 12 month

• Overall survival

  up to 36 month

Study Arms (1)

lparomlimab and Tuvonralimab Injection in Combination with Nab-Paclitaxel

EXPERIMENTAL

lparomlimab and Tuvonralimab Injection in Combination with Nab-Paclitaxel

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

Interventions

lparomlimab and Tuvonralimab Injection in Combination with Nab-Paclitaxel DRUG

Iparomlimab and Tuvonralimab Injection: 5 mg/kg, q3w; Nab-Paclitaxel: 125 mg/m² on d1 and d8, q3w; Neoadjuvant therapy is administered for 4 cycles. The appropriate surgical timing will be determined by the physician based on the patient's condition, and surgery is scheduled for 4-6 weeks after the completion of neoadjuvant therapy.

lparomlimab and Tuvonralimab Injection in Combination with Nab-Paclitaxel

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300000, China

Location

MeSH Terms

Interventions

130-nm albumin-bound paclitaxel

Central Study Contacts

Zhansheng Jiang, Doctor

CONTACT

13512035574; 18526812877@163.com

Chang Liu

CONTACT

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: March 19, 2026
• First Posted: March 27, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): December 31, 2030
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)