A Multicenter, Prospective Single-arm Study of Multimodal Thermal Therapy Combined With Toripalimab and AG Chemotherapy in the Treatment of Advanced Pancreatic Cancer (SMP1-13115)
This study is a multicenter, prospective, single-arm, open-label, Simon two-stage phase II clinical trial designed to evaluate the conversion therapeutic value of multimodal thermal therapy combined with TIS (Toripalimab) and AG chemotherapy (gemcitabine plus nab-paclitaxel) in previously untreated metastatic pancreatic cancer patients with liver-only or lung-only metastases.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: baiyong shen
- Número de teléfono: +86 18817821319
- Correo electrónico: shenby@shsmu.edu.cn
Ubicaciones de estudio
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Shandong
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Qingdao, Shandong, Porcelana
- The Affiliated Hospital of Qingdao University Medical College
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Contacto:
- xiao hu
- Número de teléfono: +86 53282911869
- Correo electrónico: 8371270@qq.com
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Porcelana, 200000
- Shanghai General Hospital
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Contacto:
- jiang long
- Número de teléfono: +86 18017317460
- Correo electrónico: jiang.long@shgh.cn
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Shanghai, Shanghai Municipality, Porcelana, 200000
- Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
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Contacto:
- baiyong shen
- Número de teléfono: +86 18817821319
- Correo electrónico: shenby@shsmu.edu.cn
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Shanxi
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Xi’an, Shanxi, Porcelana
- The First Affiliated Hospital of Xi'an Jiaotong University School of Medicine
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Contacto:
- zheng wang
- Número de teléfono: 400-000-3222
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Sichuan
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Chengdu, Sichuan, Porcelana
- West China Hospital, Sichuan University
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Contacto:
- zhong wu
- Número de teléfono: +86 18980606518
- Correo electrónico: wuzhong057@scu.edu.cn
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- 1. Aged 18-75 years, regardless of gender;
- 2. Histologically or cytologically confirmed pancreatic ductal adenocarcinoma;
- 3. Metastatic pancreatic cancer assessed by MDT as initially unresectable, with metastases confined solely to the liver or lungs, and no metastases to other organs beyond the liver or lungs;
- 4. Liver or lung metastases: number of lesions ≤ 3, and maximum diameter of each lesion ≤ 3 cm;
- 5. No prior systemic therapy for pancreatic cancer;
- 6. ECOG PS 0-1;
- 7. Child-Pugh score ≤ 7;
- 8. Voluntarily signed informed consent form.
Exclusion Criteria:
- 1. Diffuse hepatic/pulmonary metastasis;
- 2. Participation in another interventional clinical study treatment within 4 weeks;
- 3. Diagnosis of any other malignant disease other than pancreatic cancer within 5 years prior to the first dose (excluding cured cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, and/or radically resected carcinoma in situ);
- 4. History of solid organ or hematopoietic stem cell transplantation;
- 5. Suffering from any disease requiring systemic treatment with corticosteroids (prednisone or equivalent at a daily dose >10 mg) or other immunosuppressive drugs within 14 days prior to enrollment;
- 6. Previous or current diagnosis of brain metastases with symptoms not fully controlled (i.e., persistent or worsening symptoms, or requiring adjustment of symptomatic treatment to maintain symptom relief);
- 7. Uncontrolled active infection;
- 8. Renal dysfunction: serum creatinine >176.8 μmol/L or creatinine clearance <30 ml/min;
- 9. Uncorrectable abnormal coagulation function: platelet count <50×10⁹/L, prothrombin time >18 s, prothrombin activity <40%, and uncorrectable;
- 10. History of ruptured esophagogastric varices that have not been effectively treated by endoscopy, interventional therapy, or surgery;
- 11. Patients with psychiatric disorders in the active phase;
- 12. Pregnant or lactating women, or women of childbearing age who plan to become pregnant within 3 months after the end of study treatment;
- 13. Expected survival <3 months;
- 14. Any other factors that the investigator deems unsuitable for inclusion or that may affect the subject's participation in the study.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Treatment Group
multimodal thermal therapy combined with TIS (Toripalimab) and AG chemotherapy (gemcitabine plus nab-paclitaxel) |
The MTT system is a medical device that performs sequential ablation therapy. Treatment consists of initial cryoablation followed immediately by radiofrequency ablation (RFA) to achieve a synergistic thermal effect against the tumor. Toripalimab is a humanized IgG4 monoclonal antibody against programmed death-1 (PD-1). It is administered via intravenous infusion at a standard dose according to the protocol to block the PD-1/PD-L1 pathway and enhance anti-tumor immunity. Gemcitabine combined with nab-paclitaxel (albumin-bound paclitaxel) is a standard chemotherapy regimen for advanced pancreatic cancer. Both drugs are administered via intravenous infusion according to the clinical protocol to inhibit cancer cell proliferation and division. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Conversion success rate
Periodo de tiempo: From the start of treatment (Multimodal Thermal Therapy) until the evaluation of surgical conversion following at least 4 cycles of subsequent combination therapy, assessed up to 2 years
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Percentage of subjects achieving successful conversion among all enrolled subjects |
From the start of treatment (Multimodal Thermal Therapy) until the evaluation of surgical conversion following at least 4 cycles of subsequent combination therapy, assessed up to 2 years
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Progression-Free Survival(RECIST 1.1)
Periodo de tiempo: From the start of treatment until documented disease progression or death, assessed up to 2 years
|
Time from the start of treatment until disease progression (according to RECIST 1.1 based on enhanced abdominal/chest-abnormal CT or MRI every 6-8 weeks) or death from any cause, whichever occurs first. |
From the start of treatment until documented disease progression or death, assessed up to 2 years
|
|
Recurrence-Free Survival
Periodo de tiempo: From the date of radical surgical resection until disease recurrence or death from any cause, assessed up to 2 years
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From the date of radical surgical resection to the first confirmed disease recurrence by imaging or pathology, or death from any cause, whichever occurs first. Disease recurrence, including local recurrence and distant metastasis, is assessed by imaging examinations (CT/MRI ± PET-CT) or confirmed by histopathological evidence. For patients without recurrence, follow-up data will be censored at the date of the last disease assessment. |
From the date of radical surgical resection until disease recurrence or death from any cause, assessed up to 2 years
|
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Overall Survival
Periodo de tiempo: up to approximately 24 months
|
Time from the date of first study intervention to the date of death from any cause or the date of the last confirmed survival follow-up. Long-term survival will be tracked through regular follow-up visits until death, loss to follow-up, or study termination. |
up to approximately 24 months
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|
Objective Response Rate
Periodo de tiempo: up to approximately 24 months
|
Imageological evaluation was conducted according to the RECIST 1.1 criteria for solid tumors. Target lesions included both the primary pancreatic tumor in situ and measurable metastatic lesions in the liver or lungs. Quantitative measurement of the longest diameter of each target lesion was performed using contrast-enhanced CT or MRI, and the sum of the longest diameters was calculated to determine the change, thereby assessing tumor response. |
up to approximately 24 months
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Incidence of Adverse Events
Periodo de tiempo: From the first study intervention until 30 days after the last treatment or up to 24 months
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The incidence, severity, and type of adverse events (AEs) and serious adverse events (SAEs) evaluated according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v6.0), as well as changes in laboratory tests, vital signs, and physical examinations. |
From the first study intervention until 30 days after the last treatment or up to 24 months
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades del sistema endocrino
- Procesos Patológicos
- Neoplasias por sitio
- Neoplasias
- Neoplasias del Sistema Digestivo
- Enfermedades del Sistema Digestivo
- Neoplasias de glándulas endocrinas
- Enfermedades pancreáticas
- Procesos Neoplásicos
- Condiciones Patológicas, Signos y Síntomas
- Metástasis de neoplasias
- Neoplasias pancreáticas
- Compuestos heterocíclicos, 1 anillo
- Compuestos heterocíclicos
- Terapéutica
- Terapia con drogas
- Desoxicitidina
- Citidina
- Nucleósidos de pirimidina
- Pirimidinas
- Gemcitabina
- Sistemas de administración de medicamentos
- toripalimab
- Paclitaxel de 130 nm en albúmina
Otros números de identificación del estudio
- SMP1-13115
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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