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Université de médecine de TianjinClinical 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 Phase II 26
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L'essai clinique NCT07493993 est conçu pour étudier le traitement de CESO. Il s'agit d'une étude interventionnel en Phase II. Son statut actuel est : pas encore en recrutement. Le recrutement est prévu pour commencer le 1 juin 2026, avec un objectif de 26 participants. Dirigée par l'Université de médecine de Tianjin, l'étude devrait être terminée d'ici le 31 décembre 2030. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 27 mars 2026.
Résumé succinct
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.
Description détaillée
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...Afficher plus
Titre officiel
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
Pathologies
CESOAutres identifiants de l'étude
- E20260292
Numéro NCT
Date de début (réel)
2026-06-01
Dernière mise à jour publiée
2026-03-27
Date de fin (estimée)
2030-12-31
Inscription (estimée)
26
Type d'étude
Interventionnel
PHASE
Phase II
Statut
Pas encore en recrutement
Mots clés
Iparomlimab and Tuvonralimab Injection
Nab-Paclitaxel
neoadjuvant therapy
ESCC
Nab-Paclitaxel
neoadjuvant therapy
ESCC
Objectif principal
Traitement
Méthode d'allocation
N/A
Modèle d'intervention
Groupe unique
Masquage
Aucun (ouvert)
Bras / Interventions
| Groupe de participants/Bras | Intervention/Traitement |
|---|---|
Expérimentallparomlimab 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. |
Critère principal d'évaluation
Critère secondaire d'évaluation
| Critères d'évaluation | Description de la mesure | Période |
|---|---|---|
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 |
| Critères d'évaluation | Description de la mesure | Période |
|---|---|---|
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 |
Assistant à la participation
Critères d'éligibilité
Âges éligibles
Adulte, Adulte âgé
Âge minimum
18 Years
Sexes éligibles
Tous
- 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.
Université de médecine de Tianjin378 essais cliniques actifs à explorerContact central de l'étude
Contact: Zhansheng Jiang, Doctor, 13512035574, [email protected]
Contact: Chang Liu
1 Centres de l'étude dans 1 pays
Tianjin Municipality
Tianjin Medical University Cancer Institute and Hospital, Tianjin, Tianjin Municipality, 300000, China
Zhansheng Jiang, Contact, 13512035574, [email protected]