Clinical trial · Interventional
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
NCT07493993CI-TRIAL-00106562not yet recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| ESCC | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| lparomlimab and Tuvonralimab Injection in Combination with Nab-Paclitaxel | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- lparomlimab and Tuvonralimab Injection in Combination with Nab-Paclitaxel
- description
- lparomlimab and Tuvonralimab Injection in Combination with Nab-Paclitaxel
- interventionNames
- Drug: lparomlimab and Tuvonralimab Injection in Combination with Nab-Paclitaxel
Primary outcomes (1)
- measure
- Pathologic complete response rate (pCR)
- timeFrame
- up to 6 month
- description
- refers to the absence of viable tumor cells in both the primary tumor bed and the regional lymph nodes in the surgically resected specimens.
Secondary outcomes (6)
- measure
- Major Pathologic Response rate (MPR)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.