KCT0008250尚未招募未知
First-line trastuzumab, gemcitabine, cisplatin and nivolumab in advanced HER2-positive biliary tract cancer: a multicenter, openlabel, single-arm phase Ib/II trial (HERBOT)
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 入组人数
- 44
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1. Subjects with histologically- or cytologically-confirmed biliary tract cancer (including intrahepatic
- •cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gall bladder cancer)
- •2. HER2 positive biliary tract cancer (IHC 3+ or 2+ with ISH + (HER2/CEP17=2.0) or ERBB2 gene
- •copy number = 6.0 by NGS)
- •3. Age (at the time of informed consent): 20 years and older
- •4. Previously untreated if unresectable/metastatic at initial diagnosis; or recurrent disease >6 months after
- •curative surgery or adjuvant therapy (allow up to 1 cycle of gemcitabine-based chemotherapy for
- •advanced/unresectable or metastatic cholangiocarcinoma prior to enrollment)
- •5. Explicit and voluntary consent to participate in the study obtained using a signed and dated informed
- •consent form clearly and fully describing the purpose, potential risks, and any other critical issues
- •regarding the study.
- •6. Subject with measurable lesions according to RECIST v. 1.1
- •7. ECOG Performance Status Score 0 or 1
- •8. Patients with a life expectancy of at least 3 months
- •9. Patients whose latest laboratory data meet the below criteria within 14 days before enrollment. If the
- •date of the laboratory tests at the time of screening is not within 7 days before the first dose of the
- •investigational product, testing must be repeated within 7 days before the first dose of the
- •investigational product, and these latest laboratory tests must meet the following criteria. Of note,
- •laboratory data will not be valid if the patient has received a granulocyte colony-stimulating factor (GCSF)
- •or blood transfusion within 14 days before testing.
- •White blood cells =2,000/mm3 and neutrophils =1,500/mm3
- •Platelets =100,000/mm3
- •Hemoglobin =9.0 g/dL
- •AST (GOT) and ALT (GPT) =3.0-fold the upper limit of normal (ULN) of the study site (or =5.0-
- •fold the ULN of the study site in patients with liver metastases)
- •Total bilirubin =1.5-fold the ULN of the study site
- •Creatinine =1.5-fold the ULN of the study site or creatinine clearance (either the measured or
- •estimated value using the Cockcroft-Gault equation) >45 mL/min
- •INR =1.5-fold or prothrombin time =1.5-fold the ULN of the study site
- •aPTT =1.5-fold the ULN of the study site
- •10. Women of childbearing potential (including women with chemical menopause or no menstruation for
- •other medical reasons) #1 must agree to use contraception#2 from the time of informed consent until 5
- •months or more after the last dose of the investigational product. Also, women must agree not to
- •breastfeed from the time of informed consent until 5 months or more after the last dose of the
- •investigational product.
- •11. Men must agree to use contraception#2 from the start of study treatment until 7 months or more after
- •the last dose of the investigational product. #1. Women of childbearing potential are defined as all women after the onset of menstruation who are
- •not postmenopausal and have not been surgically sterilized (e.g., hysterectomy, bilateral tubal ligation,
- •bilateral oophorectomy). Postmenopause is defined as amenorrhea for =12 consecutive months without
- •specific reasons. Women using oral contraceptives, intrauterine devices, or mechanical contraception
- •such as contraceptive barriers are regarded as having childbearing potential.
- •#2. The subject must consent to use any of the following methods of contraception: vasectomy or
- •condom for patients who ar
排除标准
- •1. Patients treated with systemic chemotherapy, biologic therapy, immunotherapy, hormone therapy, or
- •clinical trials for unresectable, locally advanced or metastatic biliary tract cancer. However, the
- •following are excluded.
- •a. If disease recurrence occurs 6 months after the last dose of adjuvant chemotherapy, previous
- •adjuvant chemotherapy is permitted.
- •b. 1 cycle of Gemcitabine-based anticancer therapy for locally advanced or metastatic
- •cholangiocarcinoma prior to enrollment in this trial is permitted.
- •2. Patients with multiple primary cancers (with the exception of completely resected basal cell
- •carcinoma, stage I squamous cell carcinoma, carcinoma in situ, intramucosal carcinoma, or superficial
- •bladder cancer, or any other cancer that has not recurred for at least 5 years)
- •3. Patients with residual adverse effects of prior therapy or effects of surgery that would affect the safety
- •evaluation of the investigational product in the opinion of the investigator or sub-investigator.
- •4. Patients with current or past history of severe hypersensitivity to any other antibody products
- •5. Patients with concurrent autoimmune disease or history of chronic or recurrent autoimmune disease
- •6. Patients with a current or past history of interstitial lung disease or pulmonary fibrosis diagnosed based
- •on imaging or clinical findings. Patients with radiation pneumonitis may be enrolled if the radiation
- •pneumonitis has been confirmed as stable (beyond acute phase) without any concerns about
- •recurrence.
- •7. Patients with concurrent diverticulitis or symptomatic gastrointestinal ulcerative disease
- •8. Patients with any metastasis in the brain or meninx that is symptomatic or requires treatment. Patients
- •may be enrolled if the metastasis is asymptomatic and requires no treatment.
- •9. Patients with pericardial fluid, pleural effusion, or ascites requiring treatment
- •10. Patients with uncontrollable, tumor-related pain
- •11. Patients who have experienced a transient ischemic attack or cerebrovascular accident within 180 days
- •before enrollment
- •12. Patients with a history of uncontrollable or significant cardiovascular disease meeting any of the
- •following criteria:
- •? Myocardial infarction within 180 days before enrollment
- •? Uncontrollable angina pectoris within 180 days before enrollment ? New York Heart Association (NYHA) Class III or IV congestive heart failure
- •? Uncontrollable hypertension despite appropriate treatment (e.g., systolic blood pressure =150
- •mmHg or diastolic blood pressure = 90 mmHg lasting 24 hours or more)
- •? Arrhythmia requiring treatment
- •13. Patients with uncontrollable diabetes mellitus
- •14. Patients with systemic infections requiring treatment (infection controlled by oral antibiotics is
- •15. Patients who have received systemic corticosteroids (prednisolone or equivalent > 10mg/day) (except
- •for temporary use, e.g., for examination or prophylaxis of allergic reactions) or immunosuppressants
- •within 28 days before enrollment
- •16. Patients who have received antineoplastic drugs (e.g., chemotherapy agents, molecular-targeted
- •therapy agents, or immunotherapy agents) within 28 days before enrollment
- •17. Patients who have undergone surgical adhesion of the pleura or pericardium within 28 days before
- •18. Patients who have undergone surgery under general anesthesia within 28 days before enrollment
- •19. Patients who have undergone surgery involving loc
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