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Tianjin Medische UniversiteitClinical 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 Fase 2 26
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De klinische studie NCT07493993 onderzoekt behandeling bij ESCC. Deze Fase 2 interventioneel studie heeft de status nog niet rekruterend. De inclusie van 26 deelnemers begint op 1 juni 2026. De studie wordt geleid door Tianjin Medische Universiteit en de voltooiing is gepland op 31 december 2030. Laatste update op ClinicalTrials.gov: 27 maart 2026.
Beknopte samenvatting
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.
Uitgebreide beschrijving
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 th...Toon meer
Officiële titel
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
Aandoeningen
ESCCAndere studie-ID's
- E20260292
NCT-ID
Startdatum (Werkelijk)
2026-06-01
Laatste update geplaatst
2026-03-27
Verwachte einddatum
2030-12-31
Inschrijving (Geschat)
26
Studietype
Interventioneel
FASE
Fase 2
Status
Nog niet rekruterend
Trefwoorden
Iparomlimab and Tuvonralimab Injection
Nab-Paclitaxel
neoadjuvant therapy
ESCC
Nab-Paclitaxel
neoadjuvant therapy
ESCC
Primaire doel
Behandeling
Toewijzing
N.v.t.
Interventiemodel
Enkele groep
Blindering
Geen (Open-label)
Armen / Interventies
| Deelnemersgroep/Studiearm | Interventie/Behandeling |
|---|---|
Experimenteellparomlimab and Tuvonralimab Injection in Combination with Nab-Paclitaxel lparomlimab and Tuvonralimab Injection in Combination with Nab-Paclitaxel | lparomlimab and Tuvonralimab Injection in Combination with Nab-Paclitaxel 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. |
Primaire uitkomst
Secundaire uitkomst
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
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 |
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
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 | Os was defined as the time from the first dose of study drug to death due to anycause. | up to 36 month |
Adverse Events | An AE was defined as any untoward medical occurrence in a pharmaceutical productwhich does not necessarily have to have a causal relationship with this treatment. | up to 36 month |
Deelname-assistent
Geschiktheidscriteria
Leeftijd van deelnemers
Volwassene, Oudere volwassene
Minimumleeftijd
18 Years
Geslachten die in aanmerking komen voor de studie
Allen
- 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.
- 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.
Tianjin Medische Universiteit378 actieve klinische studies om te verkennenCentraal Contactpersoon
Contact: Zhansheng Jiang, Doctor, 13512035574, [email protected]
Contact: Chang Liu
1 Studielocaties in 1 landen
Tianjin Municipality
Tianjin Medical University Cancer Institute and Hospital, Tianjin, Tianjin Municipality, 300000, China
Zhansheng Jiang, Contact, 13512035574, [email protected]