Surufatinib Combined With Toripalimab and AG Regiments for First-line Treatment of Unresectable o… (NCT06062485) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Surufatinib Combined With Toripalimab and AG Regiments for First-line Treatment of Unresectable or Relapsing Metastatic Ampullary Carcinoma
30 participantsStarted 2023-10
Plain-language summary
A Phase Ⅱ, single-arm study to assess the safety, tolerability, and efficacy of Surufatinib Combination With Toripalimab in Patients With recurrent or metastatic ampulla tumors.
Who can participate
Age range
18 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
. Over 18 years old;
. Unresectable or relapses metastatic ampullary malignancies identified by histopathology or cytology,with histological subtypes of parenteral type;
. Have not received systematic treatment for unresectable or metastatic ampulla malignant tumor;A scheme of adjuvant or neoadjuvant chemotherapy and 6 months after the chemotherapy recurrence can into the group;
. ECOG score 0 or 1;
. Expected survival≥12 weeks;
. Have at least one measurable lesion;
. Major organ functions within 7 days prior to treatment shall meet the following criteria:
.Biochemical examination shall meet the following standards:
Exclusion criteria
. Patients who have previously been treated with small-molecule drugs similar to VEGFR-TKI,such as Anlotinib,Sunitinib,Sorafenib,Lenvatinib,Apatinib,etc.
. Anti-pd-1 or anti-PD-L1/L2 antibodies or anti-cytotoxic T lymphocyte-associated antigen(CTLA-4)antibodies were used in the past;
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.
What they're measuring
1
Objective response rate (ORR)
Timeframe: from randomization up to progressive disease or EOT due to any cause, assessed up to 2 year
Trial details
NCT IDNCT06062485
SponsorThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
. Malignant ampulla obstruction after clinical intervention was not resolved or anti-infective therapy was required 14 days before the first study of drug therapy;
. Patients with severe allergic history or allergic constitution;
. Pregnant or lactating women;
. Patients who have participated in other clinical trials and have not terminated the trials;
. Patients with any severe and/or uncontrolled medical condition,including:
.Received major surgical treatment,open biopsy,or significant traumatic injury within 28 days prior to grouping(specifically in conjunction with clinical evaluation);