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 range18 Years

SexALL

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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;
✕. 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);

What they're measuring

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

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-10

Contact for this trial

Du Juan, M.D. Ph.D

86-025-83106666 dujunglyy@163.com

View on ClinicalTrials.gov More Ampullary Carcinoma trials