A Safety and Efficacy Study of Surufatinib Combination With Toripalimab in Patients With Recurrent Biliary Tract Cancer

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Brief Title

A Safety and Efficacy Study of Surufatinib Combination With Toripalimab in Patients With Recurrent Biliary Tract Cancer

Official Title

A Safety and Efficacy Study of Surufatinib Combination With Toripalimab in Patients With Recurrent Biliary Tract Cancer : a Phase Ⅱ Study

Brief Summary

      A Phase Ⅱ, open-label, single-arm study to assess the safety, tolerability, and efficacy of
      Surufatinib Combination With Toripalimab in Patients With Recurrent Biliary Tract Cancer.
    

Detailed Description

      A Phase 2, open-label, single-arm study to assess the safety, tolerability, and efficacy of
      Surufatinib Combination With Toripalimab in Patients With Recurrent Biliary Tract Cancer
      (intrahepatic or extrahepatic cholangiocarcinoma, gallbladder cancer).
    


Study Type

Interventional


Primary Outcome

Objective response rate(ORR)

Secondary Outcome

 Progression-free survival (PFS)

Condition

Biliary Tract Cancer

Intervention

Surufatinib Toripalimab

Study Arms / Comparison Groups

 Biliary Tract Cancer
Description:  Surufatinib 250mg/Toripalimab 240mg

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

30

Start Date

September 1, 2021

Completion Date

June 2024

Primary Completion Date

June 2022

Eligibility Criteria

        Inclusion Criteria:

          1. Male and Female aged between 18 and 75 years are eligible; Provision of written
             Informed Consent Form (ICF) prior to any study specific procedures;

          2. Advanced (unresectable) or metastatic biliary carcinomas that have been histologically
             or cytologically confirmed include intrahepatic or extrahepatic carcinoma of the bile
             duct, carcinoma of the gallbladder, and carcinoma of the ampullary of fatt, and have
             been histologically confirmed as adenocarcinoma;

          3. Patients who have previously received disease progression or toxic side effects after
             first-line systemic chemotherapy are not tolerated;The standard first-line
             chemotherapy regimen was defined as a two-drug combination regimen of gemcitabine plus
             cisplatin, gemcitabine plus gio, or capecitabine plus oxaliplatin.Failure of
             first-line standard chemotherapy was defined as progression of disease during
             treatment or within 6 months after the last treatment;Or the toxic side effects of the
             treatment process are intolerable;

          4. Presence of at least one measurable target lesion for further evaluation according to
             RECIST criteria;

          5. Patients who had previously received A VEGF or VEGFR-targeted drug required
             progression 4 months after the last dose;

          6. No systemic antitumor therapy in 4 weeks;

          7. The patient has no evidence of biliary obstruction unless the obstruction is
             controlled by local treatment or the patient is decompressed by endoscopic or
             percutaneous stenting, and bilirubin is subsequently reduced to below the upper limit
             of 1.5x normal (ULN);

          8. Eastern Cooperative Oncology Group (ECOG) performance status 0-1;Predicted survival ≥3
             months;

          9. Screening laboratory values must meet the following criteria (within past 14 days):

               -  neutrophils ≥1.5×109/L ;

               -  platelets ≥9g/dL;

               -  hemoglobin ≥ 9.0 g/dL;

               -  albumin≥3g/dL;

               -  total bilirubin ≤ 1.5 x upper limit of normal (ULN); aspartic transaminase (AST)
                  and alanine transaminase (ALT) ≤ 2.5 x ULN without, and ≤ 5 x ULN with hepatic
                  metastasis; serum creatinine ≤1.5╳ULN;

         10. Voluntary enrollment, good compliance, can cooperate with the experiment observation,
             and signed a written informed consent;

         11. Males or female of childbearing potential must: agree to use using a reliable form of
             contraception (eg, oral contraceptives, intrauterine device, control sex desire,
             double barrier method of condom and spermicidal) during the treatment period and for
             at least 6 months after the last dose of study drug.

        Exclusion Criteria:

          1. Prior treatment with Surufatinib,or other antiangiogenic drugs were used within 6
             months;

          2. Prior antitumor therapy with chemotherapy, radical radiation therapy ,biological
             immunotherapy,targeted therapy within 4 weeks.

          3. Prior participation in other clinical trials not approved or listed in China within
             past 4 weeks;

          4. Prior major surgery within past 4 weeks (diagnostic surgery excluded);

          5. International standardized ratio (INR) >1.5 or partially activated prothrombin time
             (APTT) >1.5×ULN;

          6. Clinically significant severe electrolyte abnormality judged by investigator ;

          7. Hypertension that is not controlled by the drug, and is defined as: SBP≥140 mmHg
             and/or DBP≥90 mmHg;

          8. Currently suffering from poorly controlled diabetes (after regular treatment, fasting
             plasma glucose concentration ≥10mmol/L);

          9. The patient currently has disease or condition that affects the absorption of the
             drug, or the patient cannot be administered orally;

         10. Digestive tract disease such as gastric and duodenal active ulcer, ulcerative colitis
             or unresected tumor, or other conditions determined by the investigator that may cause
             gastrointestinal bleeding and perforation;

         11. Evidence of bleeding tendency or history within 3 months, or thromboembolic event
             (including a stroke event and/or a transient ischemic attack) occurred within 12
             month;

         12. Cardiovascular disease of significant clinical significance (myocardial infarction,
             unstable arrhythmia or unstable angina ,Coronary Artery Bypass Grafting within past 6
             months,);

         13. Had other malignant tumors in the past 5 years (except for basal cell carcinoma or
             squamous cell carcinoma, cervical carcinoma in situ that have been effectively
             controlled);

         14. Active or uncontrolled severe infection (≥CTCAE2 infection);

         15. Positive tests for HIV, HCV, HBsAg or HBcAb with positive test for HBV DNA
             (>2000IU/ml);

         16. Evidence with active CNS disease or previous brain metastases;

         17. The toxicity associated with previous anti-tumor treatment has not recovered to
             ≤CTCAE1, except for peripheral neurotoxicity and alopecia ≤CTCAE2 caused by
             oxaliplatin;

         18. Pregnant or nursing;

         19. Transfusion therapy, blood products and hematopoietic factors, such as albumin and
             granulocyte colony stimulating factor (G-CSF), had been received within 14 days before
             enrollment;

         20. Tumor involving skin and/or pharyngeal mucosa with ulceration;

         21. Patients with a history of psychotropic drug abuse and unable to quit or with mental
             disorders;

         22. Any other disease, with clinical significance of metabolic abnormalities, abnormal
             physical examination or laboratory abnormalities, according to researchers, there is
             reason to doubt is not suitable for the use of study drugs in patients with a disease
             or condition (such as have a seizure and require treatment), or will affect the
             interpretation of results, or make the patients at high risk.

         23. Routine urine indicated that urine protein ≥2+, and the 24-hour urine protein volume
             >1.0g;

         24. Underlying medical condition that, in the Investigator's opinion, would increase the
             risks of study drug administration or obscure the interpretation of toxicity
             determination or adverse events.

         25. Prior receipt of any anti-PD-1 /PD-L1/PD-L2 antibody or anti-cytotoxic T lymphocyte
             associated antigen-4 (CTLA-4) antibody or any other antibody acting on T cell
             co-stimulation or checkpoint pathway (e.g. OX40, CD137, etc.)
      

Gender

All

Ages

18 Years - 75 Years

Accepts Healthy Volunteers

No

Contacts

Renhao Wang, MD, 13605207887, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT05056116

Organization ID

HMPL-012-SPRING-B101


Responsible Party

Sponsor

Study Sponsor

The Affiliated Hospital of Xuzhou Medical University


Study Sponsor

Renhao Wang, MD, Principal Investigator, The Affiliated Hospital of Xuzhou Medical University


Verification Date

September 2021