NCT04155671Unknown2 期
A Phase 2 Study of POF(Paclitaxel/Oxaliplatin/5-Fluorouracil/Leucovorin) Versus FOLFOX Plus Intraperitoneal Paclitaxel as a First-line Treatment in Advanced Gastric Cancer With Peritoneal Metastases
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 260
- 主要终点
- Overall Survival(OS)
研究概览
简要总结
The aim of this study was to compare the efficacy and safety of intravenous or intraperitoneal paclitaxel plus FOLFOX as first-line treatment in AGC with peritoneal metastases, a phase II Clinical trial.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-75 years old;
- •Patients must have histologically or cytologically confirmed metastatic or unresectable gastric or gastroesophageal junction (GEJ) adenocarcinoma. GEJ adenocarcinoma may be classified according to Siewert's classification type I, II, or III
- •Histological documentation of local recurrence or metastasis is strongly encouraged, unless the risk of such a procedure outweighs the potential benefit of confirming the metastatic disease.
- •If no histologic confirmation, then the metastases or recurrence will require documentation by a 2nd radiographic procedure (eg. PET/CT scan or MRI in addition to the CT scan). If the imaging procedure does not confirm recurrent or metastatic disease, biopsy confirmation will be required.
- •Patients must have ascites or peritoneal carcinomatosis confirmed by image (CT or MR or US or others) operation.
- •Patients may have received no prior chemotherapy for metastatic or unresectable disease. Patients may have received prior adjuvant therapy (chemotherapy and/or chemoradiation) if more than 6 months have elapsed between the end of adjuvant therapy and registration.
- •Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-1;
- •An expected survival of ≥ 3 months;
- •Major organ function has to meet the following criteria; (1) For results of blood routine test:
- •Hemoglobin (HB) ≥ 80g / L,
- •ANC(absolute neutrophil count) ≥ 1.5 × 109 / L,
- •PLT(blood platelet) ≥ 75 × 109 / L, (2) For results of biochemical tests:
- •BLT（total bilirubin） ≤ 1.25 times the upper limit of normal (ULN),
- •ALT(Alanine aminotransferase) and AST(aspartate aminotransferase ) ≤ 2.5 × ·ULN, liver metastases, if any, the ALT and AST≤ 5 × ULN,
- •Serum Cr（creatinine）≤1ULN, Endogenous creatinine clearance rate >50ml/min;
- •The patient has a PT（prothrombintime） (INR international normalized ratio) < or = to 1.5 and an PTT（Partial Thromboplastin Time）< than or = to 3 seconds above the upper limits of normal if the patientia t is not on anticoagulation. ·If a patient is on full-dose anticoagulants, the following criteria should be met for enrollment:
- •The patient must have an in-range INR (usually between 2 and 3) on a stable dose of warfarin or on stable dose of LMW(Low molecular weight) heparin
- •The patient must not have active bleeding or pathological conditions that carry high risk of bleeding (e.g. tumor involving major vessels, known varices)
- •Pregnancy test (serum or urine) has to be performed for woman of childbearing age within 7 days before enrolment and the test result must be negative.
- •Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter.
- •Ability to understand informed consent and signing of written informed consent document prior to initiation of protocol therapy.
排除标准
- •Patients who have received previous chemotherapy for the treatment of metastatic or unresectable gastric or GEJ adenocarcinoma are ineligible.
- •Patients who have received previous pre- or post-operative chemotherapy or chemoradiation are ineligible if therapy was completed less than 6 months prior to study registration. Patients must have recovered from adverse events from any previous therapy.
- •Patients with a history of another neoplastic disease within the past three years, excluding basal cell carcinoma of the skin, cervical carcinoma in situ, or nonmetastatic prostate cancer.
- •Patients with brain or central nervous system metastases, including leptomeningeal disease.
- •Pregnant (positive pregnancy test) or breast feeding.
- •Serious, non-healing wound, ulcer, or bone fracture.
- •Significant cardiac disease as defined as:
- •unstable angina, New York Heart Association (NYHA) grade II or greater, congestive heart failure, history of myocardial infarction within 6 months Evidence of bleeding diathesis or coagulopathy.
- •History of a stroke or CVA within 6 months
- •Clinically significant peripheral vascular disease.
- •Inability to comply with study and/or follow-up procedures.
- •Patients with any other medical condition or reason, in that investigator's opinion, makes the patient unstable to participate in a clinical trial.
研究组 & 干预措施
POF
Experimental
The POF regimen consisted of a 3-hour infusion of paclitaxel (135 mg/m2) followed by oxaliplatin (85 mg/m2) and Calcium Levofolinate (200 mg/m2).Subsequently, a 46-hour infusion of fluorouracil (2400 mg/m2) was administered using an ambulatory pump, repeating the cycle every 14 days. The combined chemotheraphy will be treated for 9 circle. then，the capetabine was allowed
干预措施: POF (Drug)
FOLFOX plus PAC(ip)
Experimental
The regimen consisted of oxaliplatin (85 mg/m2) and Calcium Levofolinate (200 mg/m2) plus paclitaxel (80 mg/m2) intra-peritoneally.Subsequently, a 46-hour infusion of fluorouracil (2400 mg/m2) was administered using an ambulatory pump, repeating the cycle every 14 days.
干预措施: FOLFOX plus PAC(ip) (Drug)
结局指标
主要结局
Overall Survival(OS)
时间窗: 12 months
The length of time from enrollment until the time of death
次要结局
- Adverse Event（AE）(6month)
- Objective Overall Response Rate (ORR)(6month)
研究者
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