A Phase II Study of Surufatinib Combined With Camrelizumab and mFOLFOX6 as Second-line Treatment for Advanced PRAD

Обзор

To preliminarily evaluate whether there is a survival benefit of surufatinib combined with camrelizumab and mFOLFOX6 as the second-line treatment for advanced pancreatic cancer, and to explore the feasibility of second-line and post-line treatment for advanced pancreatic cancer

Подробное описание

Second-line clinical study of surufatinib in combination with Caralizumab advanced pancreatic cancer

Вмешательства

• Препарат Surufatinib 250mg/d qd once daily
  mFOLFOX6( Oxaliplatin + Leucovorin + fluorouracil) Oxaliplatin 85mg/m2 d1+CF 400mg/m2 d1+5-FU 400mg/m2d1 /2400mg/m2 continuous intravenous injection (civ) for 46h, The drug is administered every 14 days for a total of 8-12 cycles.

Первичные конечные точки

• objective response rate (ORR) [Срок оценки: Time Frame: up to 24 months]

Вторичные конечные точки (5)

• disease control rate (DCR) [Срок оценки: Time Frame: up to 24 months]
• Progression-Free Survival (PFS) [Срок оценки: Time Frame: up to 24 months]
• overall survival (OS) [Срок оценки: Time Frame: up to 24 months]
• quality of life (QoL) [Срок оценки: Time Frame: up to 24 months]
• adverse events (AE) [Срок оценки: Time Frame: up to 24 months]

Критерии участия

Критерии включения

• Have full understanding of this study and voluntarily sign the informed consent form;
• Male and Female aged between 18 and 75 years are eligible;
• Histologically or cytologically confirmed metastatic pancreatic cancer;
• Patients who have previously failed first-line gemcitabine-based chemotherapy or have disease progression/recurrence during previous neoadjuvant/adjuvant treatment or within 6 months after the end of treatment are considered to have failed first-line systemic chemotherapy; neoadjuvant/adjuvant treatment plan Also gemcitabine-based chemotherapy;
• Presence of at least one measurable target lesion for further evaluation according to RECIST criteria;
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
• Predicted survival ≥12 weeks;
• Males or female of childbearing potential must: agree to use using a reliable form of contraception (eg, oral contraceptives, intrauterine device, control sex desire, double barrier method of condom and spermicidal) during the treatment period and for at least 6 months after the last dose of study drug.

Критерии исключения

• Participated in other anti-tumor drug clinical trials within 28 days;
• Have previously received any anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody or anti-cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) antibody or acted on T cell costimulation or checkpoints Treatment with any other antibodies of the pathway (such as OX40, CD137, etc.);
• Have previously received anti-vascular endothelial growth factor/vascular endothelial growth factor receptor (VEGF/VEGFR) targeted drug treatment;
• Those who are known to be allergic to any of the drugs in the study;
• Brain metastasis accompanied by symptoms or symptom control time <2 months;
• The subject has suffered from other malignant tumors in the past or at the same time within 5 years (except cured basal cell carcinoma of the skin and cervical cancer in situ);
• Insufficient bone marrow hematopoietic function (without blood transfusion within 14 days):

• Absolute neutrophil count (ANC) <1.5×109/L;
• Platelets <100×109/L;
• Hemoglobin <8g/dL.
• Liver abnormalities:

• When there is no liver metastasis, ALT, AST or ALP>2.5×the upper limit of the normal reference range (ULN); when there is liver metastasis, ALT, AST or ALP>5×ULN;
• Serum total bilirubin >1.5×ULN (Gilber syndrome >3×ULN);
• Decompensated cirrhosis (Child-Pugh liver function grade B or C);
• Hepatitis B surface antigen (HBsAg) positive and hepatitis B virus DNA copy number ≥2000IU/mL (those who are HBsAg positive and hepatitis B virus DNA copy number <2000IU/mL need to receive at least 2 weeks of anti-HBV treatment before taking the first dose) ;
• Hepatitis C virus (HCV) antibody positive and HCVRNA test positive.
• Kidney abnormalities:

• Serum creatinine>1.5×ULN;
• Routine urine test shows urine protein ≥++, and the 24-hour urine protein quantification is confirmed to be >1.0g;
• Renal failure requiring hemodialysis or peritoneal dialysis;
• Past history of nephrotic syndrome.；

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• SunYat-senUniversity Cancer Center — Гуанчжоу

Идентификаторы

NCT: NCT06329947 · HMPL-012-SPRING-P106

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗