NCT07795749招募中2 期
Phase II Basket Trial of Intraperitoneal Paclitaxel Plus Systemic Therapy in Gastrointestinal Malignancies With Peritoneal Carcinomatosis (STOPGAP - B)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Protocol Treatment Completion Rate
研究概览
简要总结
This is a phase II open-label, basket clinical trial to assess the feasibility of systemic and Intraperitoneal chemotherapy in subjects with Gastrointestinal Malignancies with Peritoneal Carcinomatosis. These are subjects who have a proven primary carcinoma of the digestive tract..
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cohort A: Patients must have histologically or cytologically confirmed primary gastric or gastroesophageal adenocarcinoma with a clinical diagnosis of metachronous PC with a history of prior gastric cancer resection. Extraperitoneal metastases are allowed.
- •Cohort B: Patients must have histologically or cytologically confirmed primary colorectal or appendiceal adenocarcinoma with PC . Extraperitoneal metastases are allowed. Patients with PC amenable to cytoreductive surgery (CRS) without the need for upfront systemic therapy as determined by a peritoneal malignancy surgeon within 4 weeks prior to enrollment are excluded.
- •Cohort C: Patients must have adenocarcinomas of the digestive tract with PC not included in Cohorts A and B (including but not limited to carcinomas of the small bowel and hepatobiliary tract).
- •Must have peritoneal cytology positive disease or peritoneal carcinomatosis detected by imaging, laparoscopy or laparotomy
- •Performance status: ECOG performance status ≤ 2 (Appendix A) . ECOG 2 allowed if attributed to malignancy (rather than comorbidities)
- •Life expectancy of greater than 3 months
- •Adequate organ and marrow function as defined below: Leukocytes: ≥ 2,000/mcL; Absolute neutrophil count: ≥ 1,500/mcL (may receive gcsf); Platelets: ≥ 70,000/mcl (may receive TPO); Total bilirubin: within 2x of normal institutional limit; AST(SGOT)/ALT(SPGT): ≤5 X institutional upper limit of normal; Creatinine: < 2 X institutional upper limit of normal; Hemoglobin: Hemoglobin > 8.0 g/dL (may be transfused); Serum albumin: ≥ 2.5 g/dL
- •Ability to understand and the willingness to sign a written informed consent
排除标准
- •Any evidence of small or large bowel obstruction with the exception of gastric outlet obstruction due to primary malignancy
- •Uncontrolled intercurrent illness including, but not limited to, the following conditions: Ongoing or active infection; Symptomatic congestive heart failure; Stroke (including transient ischemic attack [TIA]), myocardial infarction (MI), or other ischemic event,) within 3 months before initiation of treatment; Unstable angina pectoris; Cardiac arrhythmia
- •History of another primary cancer within the last 3 years with the exception of non-melanoma skin cancer, early-stage prostate cancer, or curatively treated cervical carcinoma in-situ and not treated with systemic therapy.
- •History of prior iterative intraperitonealtherapy administered either as HIPEC, PIPAC or NIPEC. Single exposure to HIPEC at the time of cytreduction is not an exclusion
- •Inability to comply with study and follow-up procedures as judged by the Investigator
- •Patients must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
- •Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- •Has an active infection requiring systemic therapy.
- •Prior surgery that would preclude safe diagnostic laparoscopy and port placement
- •Has a known history of active tuberculosis (TB; Bacillus tuberculosis).
- •Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.
研究组 & 干预措施
CohtCQ3W: Cohort C Other Malignancies of the Digestive Tract (Paclitaxel Q3W)
Experimental
干预措施: Paclitaxcel Q3W (Drug)
CohtBQ2W: Cohort B Colorectal/Appendiceal Adenocarcinoma (Paclitaxel Q2W)
Experimental
干预措施: Paclitaxel Q2W (Drug)
CohtAQ2W: Chort A Gastric/Esophageal Carcinoma (Paclitaxel Q2W)
Experimental
干预措施: Paclitaxel Q2W (Drug)
CohtAQ3W: Cohort A Gastric/Esophageal Carcinoma (Paclitaxel Q3W)
Experimental
干预措施: Paclitaxcel Q3W (Drug)
CohtBQ3W: Cohort B Colorectal/Appendiceal Adenocarcinoma (Paclitaxel Q3W)
Experimental
干预措施: Paclitaxcel Q3W (Drug)
CohtCQ2W: Cohort C Other Malignancies of the Digestive Tract (Paclitaxel Q2W)
Experimental
干预措施: Paclitaxel Q2W (Drug)
结局指标
主要结局
Protocol Treatment Completion Rate
时间窗: 6 weeks
Number of patients that complete treatment at 2 cycles
次要结局
- Overall Survival of Participants(3 years)
- Participants with Progression Free Survival(3 years)
- Patient Reported Quality of Life Outcomes(1 year)
- Incidence of Treatment-Emergent Adverse Events [Safety](1 year)
- Overall Response Rate (ORR) by RECIST v1.1(1 year)
研究者
Maheswari Senthil, MD
Professor of Surgery, Division Chief - Surgical Oncology
University of California, Irvine
研究点 (1)
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