2026-526122-41-00招募中2 期
COLOVERT – Conversion therapy in colorectal cancer with peritoneal metastases not amenable to upfront cytoreductive surgery and HIPEC: a phase II “pick-the-winner” open-label randomized trial
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Objective response rates according to radiological PCI after 3 cycles of treatment.
研究概览
简要总结
To compare the difference in objective response rates (ORR) between two experimental repeat intraperitoneal chemotherapy regimens.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Provision of written informed consent prior to any study specific procedures. • ECOG Performance Status Score 0,1 or 2 alternatively Karnofsky 60-100 • Adequate kidney, liver, bone marrow function according to laboratory tests • For females of childbearing potential, a negative pregnancy test must be documented. • ≥ 18 years old and <80 years old • Colorectal cancer (>10cm from anal verge) with CT assessable synchronous or metachronous peritoneal metastases +/- primary tumor • CT-PCI > 10 (which translates often to surgical PCI >15) as judged at the HIPEC multidisciplinary board meeting but considered candidate for CRS/HIPEC in the case of significant tumor response. • CT-PCI < 10 allowed if conversion therapy is necessary to be eligible for CRS+/-HIPEC • RAS mutations and wild-type cancers can both be included. • No previous treatment for peritoneal metastatic disease
排除标准
- •Previous severe toxicity/allergic reactions to the systemic chemotherapy agents included in this study • Unable to tolerate full dose systemic chemotherapy treatment due to comorbidity or previous remaining toxicity (e.g. neurotoxicity) or DPYD deficiency • Deficient mismatch repair cancers are excluded • Previous CRS or HIPEC or other large open abdominal surgery leading to significant intraperitoneal adhesions. (laparoscopic procedures are ok) • Previous severe abdominal septicemia or other causes that may significantly increase the risk of intraperitoneal adhesions (a staging laparoscopy may be allowed to determine this) • Pregnant or lactating (nursing) women • Active infections requiring antibiotics • Active liver disease with positive serology for active hepatitis B, C, or known HIV • Concurrent administration of any cancer therapy other than planned study treatment within 4 weeks prior to and up to 4 weeks after study treatment • Lower and intermediate rectal cancers are excluded (above >10cm accepted) • Indication for preoperative radiation
结局指标
主要结局
Objective response rates according to radiological PCI after 3 cycles of treatment.
Objective response rates according to radiological PCI after 3 cycles of treatment.
次要结局
- • Conversion rate to CRS+HIPEC as determined at the second MDT. • Safety as defined by AER from date of randomization until 3 weeks after last treatment cycle. • Overall survival during 3.5 year follow-up • Progression-free survival defined as documented disease progression or death from any cause during 3.5 year follow-up • Patient-derived scaffolding and FMCA analysis will evaluate chemotherapy sensitivity and its predictive value for response rates.
研究者
Peter Cashin
Scientific
Uppsala University Hospital
研究点 (4)
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