CTIS2022-503044-40-00进行中（未招募）1 期
Preoperative immunotherapy with atezolizumab (Tecentriq®) and tiragolumab in patients with colorectal liver metastases (CRLM) (the PURPLE trial) - PURPLE
niversitaetsklinikum Essen AöR0 个研究点目标入组 18 人开始时间: 2024年5月30日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 18
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Male or female, 18 years of age or older on day of signing informed consent form, Negative human immunodeficiency virus (HIV) test at screening (see exclusion criterion 16 for exceptions), For patients with hepatitis B virus (HBV): HBV DNA < 500 IU/mL (or 2,500 copies/mL) at screening Patients with detectable hepatitis B surface antigen (HBsAg) or detectable HBV DNA should be managed per institutional treatment guidelines. Patients receiving anti-viral medication must have initiated treatment for at least 2 weeks prior to randomization and should continue treatment for at least 6 months after the final dose of study treatment, Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening The HCV RNA test will be performed only for patients who have a positive HCV antibody test., For women of childbearing potential (WCBP): A woman is considered to be of childbearing potential if she is post-menarchal, has not reached a postmenopausal state (= 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus). • Should have a negative serum pregnancy test within 14 days prior to randomization. • Agreement to remain abstinent (refrain from heterosexual intercourse) or use a contraceptive method with a failure rate of <1% per year during the treatment period and for at least 5 months after last study drug administration. • Examples of contraceptive methods with a failure rate of <1% per year include bilateral tubal ligation, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices and copper intrauterine devices. • The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or post-ovulation methods) and withdrawal are not acceptable methods of contraception, For men: Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agreement to refrain from donating sperm, as defined below: • Men with a female partner of childbearing potential or pregnant female partner: men must be sterilized or remain abstinent or use a condom during the treatment period and for 90 days after the last dose of tiragolumab to avoid exposing the embryo. • The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence and withdrawal are not acceptable methods of contraception. • Men must refrain from donating sperm during this same period., Patient is willing and able to comply with the protocl for the duration of the study including undergoing treatment and scheduled visits and examinations, Signed informed consent, Histologically confirmed adenocarcinoma [mixed adenoneuroendocrine (MANEC) are alowed, if predominant part in adenocarcinoma] of the colon or rectum with liver metastases (CRLM)(synchronous or metachronous) that are amenable to surgical resection with curative intent based on the decision of the local multidisciplinary tumor board. Two stages resections of CRLM and primary tumor is allowed according to local guidelines., CRLM have to be accessible for biopsy, Microsatellite stable (MSS)/proficient mismatch repair (pMMR) disease (as
排除标准
- •Evidence of metastases, except for liver and local lymph node metastases, History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins, Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab or tiragolumab formulation, Uncontrolled hypercalcemia (> 1.5 mmol/L ionized calcium or Ca > 12 mg/dL or corrected serum calcium > ULN) or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy or denosumab, Uncontrolled tumor-related pain. Patients requiring narcotic pain medication must be on a stable regimen at study entry Symptomatic lesions (e.g., bone metastases or metastases causing nerve impingement) amenable to palliative radiotherapy should be treated prior to enrollment. Patients should be recovered from the effects of radiation. There is no required minimum recovery period. Asymptomatic metastatic lesions that would likely cause functional deficits or intractable pain with further growth (e.g., epidural metastasis that is not currently associated with spinal cord compression) should be considered for loco-regional therapy if appropriate prior to enrollment., Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently) Patients with indwelling catheters (e.g., PleurX?) are allowed., Uncontrolled or symptomatic hypercalcemia (ionized calcium > 1.5 mmol/L, calcium > 12 mg/dL or corrected serum calcium > ULN), Positive Epstein-Barr-Virus (EBV) viral capsid antigen IgM test at screening. An EBV polymerase chain reaction (PCR) test should be performed as clinically indicated to screen for acute infection or suspected chronic active infection., Presence of severe infection within 4 weeks prior to to randomization, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia, or any active infection that, in the opinion of the investigator, could impact patient safety, Positive human immunodeficiency virus (HIV) Known HIV+ patients may be included but must have: o A stable regimen of highly active anti-retroviral therapy (HAART) for at least 3 months o No requirement for concurrent antibiotics or antifungal agents for the prevention of opportunistic infections o A CD4 count above 250 cells/mcL and an undetectable HIV viral load on standard PCR-based tests, Active hepatitis B virus (HBV) infection (chronic or acute), defined as having a positive hepatitis B surface antigen (HBsAg) test at screening, Prior treatment with immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, anti-PD-L1 and anti-TIGIT therapeutic antibodies, Patients with a past or resolved HBV infection, defined as having a negative HBsAg test and a positive total hepatitis B core antibody (HBcAb) test at screening followed by a negative HBV DNA test, are eligible for the study. The HBV DNA test will be performed only for patients who have a positive total HBcAb test., Active hepatitis C virus (HCV) infection, defined as having a positive HCV antibody test followed by a positive HCV ribonucleic acid (RNA) test at screening. The HCV RNA test will be performed only for patients who have a positive HCV antibody test, Active tuberculosis, Treatment with therapeutic oral or i.v. antibiotics within 2 weeks prior to randomization Exception: Prophylactic antibiotics (e.g., to prevent a urinary tract infection
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