A Phase II, Single-Arm, Multicenter Study of Gemcitabine and Nab-Paclitaxel in Combination With Iparomlimab and Tuvorilimab in Patients With Advanced Gallbladder Cancer
试验速览
- 阶段
- 2 期
- 状态
- Enrolling By Invitation
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- ORR
研究概览
简要总结
This is a single-arm, multicenter, Phase II clinical trial evaluating the efficacy and safety of Gemcitabine plus Nab-Paclitaxel (AG regimen) in combination with Iparomlimab and Tuvorilimab (a dual anti-PD-1/CTLA-4 bispecific antibody) in patients with advanced unresectable gallbladder cancer.
The study aims to assess the surgical conversion rate and objective response rate (ORR) as primary endpoints. Secondary endpoints include R0 resection rate, disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and safety profiles.
A total of 44 participants will be enrolled across three centers in China. The study is scheduled to run from May 2025 to April 2027.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent.
- •Age 18-75 years.
- •ECOG performance status 0-2, Child-Pugh class A.
- •Histologically or cytologically confirmed advanced gallbladder cancer, deemed unresectable for R0 resection.
- •Adequate organ function:
- •ANC ≥1.5×10⁹/L, platelets ≥75×10⁹/L, hemoglobin ≥90 g/L.
- •Serum creatinine ≤1.2 mg/dL or creatinine clearance ≥60 mL/min.
- •Total bilirubin ≤1.5×ULN (≤3×ULN if liver metastases); AST/ALT ≤3×ULN (≤5×ULN if liver metastases).
- •Life expectancy ≥3 months.
- •Non-pregnant, non-lactating women and willingness to use contraception during and for 3 months after treatment.
排除标准
- •Severe systemic infection or uncontrolled comorbidities (e.g., heart failure, thyroid disease, psychiatric disorders); active autoimmune disease requiring medication.
- •Known allergy or intolerance to chemotherapy agents.
- •Prior antitumor therapy (chemotherapy, radiotherapy, immunotherapy) within the past year, or history of other malignancies (except cured cervical carcinoma in situ or non-melanoma skin cancer).
- •Pregnancy, lactation, or unwillingness to use contraception.
- •Participation in another clinical trial within 30 days before the first dose.
- •Unwillingness to participate or inability to provide informed consent.
- •Any other condition that, in the investigator's judgment, may affect patient safety or compliance
研究组 & 干预措施
Treatment :Gemcitabine plus Nab-Paclitaxel (AG regimen) in combination with Iparomlimab and Tuvorili
Treatment :Gemcitabine plus Nab-Paclitaxel (AG regimen) in combination with Iparomlimab and Tuvorili
干预措施: Treatment :Gemcitabine plus Nab-Paclitaxel (AG regimen) in combination with Iparomlimab and Tuvorili (Drug)
结局指标
主要结局
ORR
时间窗: At the end of Cycle 6 (each cycle is 21 days)
The objective response rate (ORR) of this quadruplet regimen as first-line therapy
Surgical Conversion Rate
时间窗: At the end of Cycle 6 (each cycle is 21 days)
Proportion of patients who achieve successful conversion to radical resection (R0/R1) after systemic therapy.
次要结局
- Surgical Safety(Perioperative)
- Downstaging Rate(At the end of Cycle 6 (each cycle is 21 days))
- Disease Control Rate (DCR)(At the end of Cycle 6 (each cycle is 21 days))
- Pathologic Response Rate(At the end of Cycle 6 (each cycle is 21 days))
- Overall Survival (OS)(through study completion,up to 3 years)
- Adverse Events (AEs) / Serious AEs (SAEs)(through study completion, up to 30 days)
- R0 Resection Rate(At the end of Cycle 6 (each cycle is 21 days))
- Recurrence-Free Survival (RFS)(up to 2 years)
研究者
Wei Gong
MD.
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine