Clinical Study of Regorafenib and Nivolumab Plus Chemotherapy (NCT05394740) | Clinical Trial Compass
CompletedPhase 1/2
Clinical Study of Regorafenib and Nivolumab Plus Chemotherapy
Japan30 participantsStarted 2022-06-06
Plain-language summary
This is an open-label, single-arm, single-center Phase Ib/II study to exploratorily evaluate the tolerability, safety, and efficacy of regorafenib and nivolumab plus chemotherapy in patients with unresectable advanced/recurrent gastric/ gastroesophageal junction/esophageal adenocarcinoma.
Who can participate
Age range20 Years
SexALL
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Inclusion criteria
✓. Histologically confirmed gastric/ gastroesophageal junction/esophageal adenocarcinoma that is confirmed to be unresectable/recurrent disease
✓. At least 1 measurable lesion as defined by RECIST guideline version 1.1.
✓. Age \>= 20 years on the day informed consent is obtained
✓. ECOG Performance status (PS) 0 or 1
✓. The most recent laboratory value within 14 days prior to enrollment meets all of the following. (Examinations on the same day of the week 2 weeks prior to the day of enrollment may be utilized.) 1)Neutrophils \>= 1,200/mm\^3 2)Hemoglobin \>= 8.0 g/dL 3)Platelets \>= 75,000/mm\^3 4)Total bilirubin \<= 1.5 mg/dL 5)AST (GOT) \<= 100 IU/L If liver metastases are present: \<= 200 IU/L 6)ALT (GPT) \<= 100 IU/L If liver metastases are present: \<= 200 IU/L 7)Creatinine \<= 1.5 mg/dL 8)Urine protein: any of the following (if any of the test criteria are met, other tests may not be performed.) (i)Urine protein (dipstick) \<= 2+ (ii)Urine protein creatinine (UPC) ratio \< 3.5 (iii)Urine protein \<= 3,500 mg for 24-hour collection sample 9)PT-INR: \<= 1.5 (\<= 3.0 if on an anticoagulant)
✓. No transfusions within 7 days prior to enrollment. (Transfusions on the same day of the week prior to enrollment are allowed)
✓. Women of childbearing potential must have a negative pregnancy test within 7 days prior to enrollment. Both men and women must agree to use adequate contraception from the time of signing the informed consent form for a period of time (9 months in women and 7 months in men) after the last dose of protocol therapy
✕. Prior chemotherapy for unresectable advanced/recurrent gastric/ gastroesophageal junction/esophageal adenocarcinoma (Note: Prior neoadjuvant or adjuvant therapy is allowed. However, treatment must have been completed at least 6 months prior to enrollment and progression must have occurred at least 6 months after the completion of the therapy)
✕. HER2 positive (IHC3+, or IHC2+ and FISH positive)
✕. Patients with hypertension that is difficult to control (systolic blood pressure \>= 160 mmHg or diastolic blood pressure \>= 90 mmHg) despite multiple antihypertensive medications
✕. Patients with a history of acute coronary syndrome (including myocardial infarction and unstable angina), coronary angioplasty, or stent placement within 6 months prior to enrollment
✕. Patients with a history or evidence of congestive heart failure of Class III or higher according to the New York Heart Association (NYHA) classification
✕. Confirmed metastases to the central nervous system (Confirmation by brain computed tomography scan or magnetic resonance imaging is required at screening only if metastases to the central nervous system are clinically suspected)
✕. Active double cancers with intensive treatments and possibly affect continuation of protocol treatment