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 range
20 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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
. Oral administration is feasible
Exclusion criteria
. 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