NCT06454435尚未招募2 期
Sintilimab Combined With Fruquintinib and Chemotherapy Versus Sintilimab and Chemotherapy for Conversion Therapy in Unresectable Stage IV Gastric Cancer: a National Multicenter Randomized Controlled Study
Tianjin Medical University Cancer Institute and Hospital1 个研究点 分布在 1 个国家目标入组 158 人开始时间: 2024年6月最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 158
- 试验地点
- 1
- 主要终点
- R0-surgery conversion rate
研究概览
简要总结
This is a multicenter, randomized, open-label, phase 2 clinical study aiming to evaluate the feasibility and efficacy of sintilimab (PD-1 inhibitor) in combination of fruquintinib and chemotherapy (S-1 plus nab-paclitaxel) versus sintilimab and chemotherapy as conversion therapy in patients with stage IV gastric cancer in China.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed gastric/gastroesophageal junction adenocarcinoma through gastroscopy.
- •Ages: 18-70 Years (concluding 18 and 70 Years)
- •Life expectancy ≥3 months.
- •Treatment-naive Stage IV (clinical staging, AJCC 8th) unresectable patients, no prior antitumor therapy (including radiation, chemotherapy, targeted therapy or immunotherapy, etc.).
- •The Eastern Cooperative Oncology Group Performance status (ECOG PS) of 0-
- •Preoperative examinations using CT, MRI, PET-CT, etc., indicating only one unresectable factor OR peritoneal metastasis with another unresectable factor, such as:
- •N3 lymph node metastasis, mainly referring to group 16 lymph node metastasis.
- •Extensive or bulky lymph nodes (D2)
- •Locally advanced T4b.
- •Hepatic metastases (H1): ≤5 lesions with a total diameter ≤8cm.
- •Peritoneal metastasis (CY1, P1).
- •Ovarian metastasis (Krukenberg tumor).
- •Physically fit for major abdominal surgery.
- •Adequate organ and marrow function, defined as:
- •Hematological status: Absolute neutrophil count (ANC) ≥1.5×10^9/L; Platelet count (PLT) ≥100×10^9/L; Hemoglobin (HGB) ≥9.0 g/dL.
- •Liver function: For patients without liver metastasis, serum total bilirubin (TBIL) ≤1.5× upper limit of normal (ULN); ALT and AST ≤2.5×ULN. For patients with liver metastasis: TBIL ≤1.5×ULN; ALT and AST ≤5×ULN.
- •Renal function: Creatinine clearance (Ccr) ≥50 mL/min (calculated using the Cockcroft/Gault formula).
- •Adequate coagulation function, defined as International Normalized Ratio (INR) or Prothrombin Time (PT) ≤1.5 times ULN.
- •Voluntary participation and signed informed consent with expected good compliance and follow-up.
- •Not involved in other clinical trials.
- •Willing to provide blood and histological samples.
- •No serious conditions affecting anesthesia, or surgery.
- •No hematologic disorders affecting postoperative hemoglobin levels.
排除标准
- •Has distal metastases other than oligometastases as defined in the inclusion criteria, such as pulmonary metastases, brain metastases, bone metastases, etc.
- •HER-2 positive patients or willing to receive Trastuzumab.
- •Endoscopic signs of active bleeding from the lesion.
- •Patients with moderate/large volume of ascites.
- •Near-obstruction at the cardia or pylorus affecting feeding and gastric emptying or difficulty swallowing tablets.
- •Concurrently suffering from other serious illnesses that are difficult to control (Severe uncontrolled recurrent infections, atrial fibrillation, angina pectoris, cardiac insufficiency, ejection fraction measurement under 50%, uncontrolled hypertension, renal insufficiency, symptomatic peripheral neuropathy, and NCI classification >II)
- •Has already on other medications prior to enrollment or could not be assured of compliance after enrollment.
- •Allergy to any drugs in the regimen.
- •Women who are pregnant or breastfeeding and have childbearing potential but are not taking adequate contraceptive measures.
- •Organ transplant recipients requiring immunosuppression.
- •Patients without decision-making capacity or with psychiatric disorders.
- •Systemic treatment with Chinese herbal anti-tumor or immunomodulatory drugs (including thymosin, interferons, interleukins) within 2 weeks before the first dose.
- •Use of immunosuppressive drugs within 4 weeks before the first study treatment, excluding local steroids or physiological doses of systemic steroids.
- •Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study treatment.
- •Has a diagnosis of autoimmune disease within the previous 2 years (Patients with vitiligo, psoriasis, alopecia areata, or Graves' disease who do not require systemic therapy within the last 2 years, hypothyroidism requiring only thyroid hormone replacement therapy, and type I diabetes mellitus requiring only insulin replacement therapy are eligible for enrollment).
- •Known history of primary immunodeficiency.
- •Known to have active tuberculosis.
- •Has history of human immunodeficiency virus (HIV) infection (i.e., HIV antibody . positive); untreated acute or chronic active hepatitis B or hepatitis C infection. Patients receiving antiretroviral therapy are eligible for enrollment on an individual basis as determined by the physician with monitoring of viral copy number.
- •Urinalysis indicating urine protein ≥2+ and 24-hour urine protein quantification >1.0g.
研究组 & 干预措施
Sintilimab + Fruquinitinib + S-1 plus nab-paclitaxel
Experimental
干预措施: Sintilimab + Fruquinitinib + S-1 plus nab-paclitaxel (Drug)
Sintilimab + S-1 plus nab-paclitaxel
Active Comparator
干预措施: Sintilimab + S-1 plus nab-paclitaxel (Drug)
结局指标
主要结局
R0-surgery conversion rate
时间窗: about 3 years
The proportion of patients who underwent R0 surgery among all efficacy evaluable patients.
次要结局
- Adverse event (AEs)(about 3 years)
- Overall survival (OS)(about 3 years)
- Pathological complete response (pCR)(about 3 years)
- Major pathological response rate (MPR)(about 3 years)
- Rate of downstaging(about 3 years)
- Objective response rate (ORR)(about 3 years)
- Disease control rate (DCR)(about 3 years)
- Progression-free survival (PFS)(about 3 years)
研究者
研究点 (1)
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