A Trial Evaluating Surufatinib Efficacy and Safety in Biliary Tract Carcinoma Patients

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Brief Title

A Trial Evaluating Surufatinib Efficacy and Safety in Biliary Tract Carcinoma Patients

Official Title

A Randomized, Open, Multi-center Phase IIb/III Clinical Study to Assess the Efficacy and Safety of Surufatinib Compared to Capecitabine in Advanced or Metastatic Biliary Tract Carcinoma (BTC) Patients

Brief Summary

      This is a randomized, open-label, active-control, multi-center, phase IIb/III clinical study
      to evaluate the efficacy and safety of surufatinib vs. Capecitabine as a second-line therapy
      in patients with unresectable or metastatic biliary tract cancer (BTC). About 298 subjects
      are randomly assigned to two study treatment groups in the ratio of 1:1 by Interactive Web
      Response System (IWRS).

        -  Active group: 300 mg of surufatinib,once a day for 3 weeks as a cycle;

        -  Control group: In each 3-week cycle, Capecitabine is given at 1250 mg/m2 by oral
           administration twice a day for 2 weeks, followed by 1 week rest period (equivalent to
           2500 mg/m2 total daily dose).

      All patients will be treated based on the arm to which they have been randomized. Treatment
      on study will continue until disease progression, death, intolerable toxicity or other
      criteria for discontinuation from study treatment. The tumor assessments are performed with
      imaging every 6 weeks (+3 days) until progressive disease (RECIST v1.1) or death on the study
      treatment period, and the treatment and survival of the patients after progressive disease
      are recorded. Safety indicators include adverse events, laboratory tests, vital signs, and
      changes in electrocardiograms and echocardiograms.
    

Detailed Description

      This is a randomized, open-label, active-control, multi-center, phase IIb/III clinical study
      to evaluate the efficacy and safety of surufatinib vs. Capecitabine as a second-line therapy
      in patients with unresectable or metastatic biliary tract cancer (BTC). About 298 subjects
      are randomly assigned to two study treatment groups in the ratio of 1:1 by IWRS.

        -  Active group: 300 mg of surufatinib is given by oral administration once a day (QD)
           every 3 weeks;

        -  Control group: In each 3-week cycle, Capecitabine is given at 1250 mg/m2 by oral
           administration twice a day (BID) for 2 weeks, followed by 1 week rest period (equivalent
           to 2500 mg/m2 total daily dose).

      Patients are randomized with the following stratification factors:

        -  Eastern Cooperative Oncology Group (ECOG) Performance Status (0 or 1);

        -  Years from the first diagnosis of BTC to the randomization date (≤ 1 year or > 1 year);

        -  The primary site of the tumor (intrahepatic cholangiocarcinoma or extrahepatic
           cholangiocarcinoma or gallbladder cancer).

      All patients will be treated based on the arm to which they have been randomized. Treatment
      on study will continue until disease progression, death, intolerable toxicity or other
      criteria for discontinuation from study treatment. The tumor assessments are performed with
      imaging every 6 weeks (+3 days) until progressive disease (RECIST v1.1) or death on the study
      treatment period, and the treatment and survival of the patients after progressive disease
      are recorded. Safety indicators include adverse events, laboratory tests, vital signs, and
      changes in electrocardiograms and echocardiograms.
    

Study Phase

Phase 2/Phase 3

Study Type

Interventional


Primary Outcome

Overall survival (OS)

Secondary Outcome

 Progression-free survival (PFS)

Condition

Biliary Tract Cancer

Intervention

Surufatinib

Study Arms / Comparison Groups

 Active group
Description:  300 mg of surufatinib is given by oral administration once a day (QD) every 3 weeks;

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

298

Start Date

July 10, 2018

Completion Date

March 2022

Primary Completion Date

June 2021

Eligibility Criteria

        Inclusion Criteria:

          1. Patients are fully informed about the study and voluntarily sign the informed consent
             (prior to the implementation of any specific procedure for the trial);

          2. 18-75 years old (inclusive);

          3. Patients with histologically or cytologically confirmed unresectable or metastatic
             BTC, including intrahepatic cholangiocarcinoma (IHCC), extrahepatic cholangiocarcinoma
             (EHCC) and gallbladder cancer (GBC);

          4. Patients have failed first-line standard systemic chemotherapy. A first-line standard
             systemic chemotherapy is defined as a regimen of gemcitabine combined with
             platinum-based therapy. The failure of a first-line standard chemotherapy is defined
             by progressive disease during the treatment or within 6 months after the last
             treatment, or intolerable toxicity during the treatment.

             Note: a. The time of first-line medication is ≥ 1 cycle of combination chemotherapy;
             b. Neoadjuvant or adjuvant chemotherapy is allowed in the early stage, and should be
             considered failed as a first-line systemic chemotherapy for progressive disease if
             progressive disease/recurrence occurs during the course of the neoadjuvant/adjuvant
             therapy or within 6 months after the end of treatment; c. The previous first-line
             standard chemotherapy does not contain any small molecular anti-angiogenesis agents or
             monoclonal antibodies, or any drugs related to tumor immunity;

          5. ECOG performance status of 0 or 1 (Annex 1);

          6. Liver function with a modified Child-Pugh score of < 7;

          7. Confirmed measurable (or evaluable) lesions that meet the requirements of RECIST 1.1;

          8. Expected survival of ≥ 12 weeks;

          9. Fertile male or female patients shall volunteer to use effective contraceptive
             methods, such as double barrier contraception, condoms, oral or injected
             contraceptives, and intrauterine devices, during the study period and within 90 days
             after the last dosing of the investigational drug. All female patients will be
             considered fertile unless they have had natural menopause, or artificial menopause or
             sterilization (such as hysterectomy, bilateral adnexectomy or ovarian radiation).

        Exclusion Criteria:

          1. Received a systemic anti-cancer therapy that has been approved or in development,
             including chemotherapy, radical radiotherapy, bio-immunotherapy, targeted therapy, and
             treatment by traditional Chinese medicines (if the instructions of the traditional
             Chinese medicines specifies clear indications for anti-tumor therapy, the patient may
             be enrolled after an 1 week of washout period), within 4 weeks prior to randomization;

          2. Received a systemic chemotherapy (a neoadjuvant or adjuvant chemotherapy except those
             that have not failed within 6 months) other than gemcitabine combined with
             platinum-based therapy (such as fluorouracil-based chemotherapy) prior to
             randomization; or received an anti-tumor immunotherapy, such as PD-1 and PD-L1
             therapies;

          3. Received any surgery or invasive treatment/operation (except venous catheterization,
             puncture and drainage, etc) within 4 weeks prior to randomization;

          4. Received any major surgical operations within 60 days before randomization, or have
             any incisions that have not completely healed;

          5. Received a local anti-tumor therapy such as hepatic artery interventional
             embolization, cryoablation of liver metastases, or radiofrequency ablation within 4
             weeks prior to randomization;

          6. Patients with any of the following laboratory abnormalities:

               -  Absolute neutrophil count (ANC) < 1.5 × 109/L, or platelet (PLT) < 100 × 109/L,
                  or hemoglobin (Hb) < 90 g/L;

               -  Total bilirubin ≥ 1.5 × Upper Limit of Normal (ULN);

               -  In the absence of liver metastasis, alanine transaminase (ALT) and/or aspartate
                  transaminase (AST) ≥ 1.5 × ULN; in the presence of liver metastasis, ALT and/or
                  AST ≥ 3 × ULN;

               -  Serum creatinine ≥ 1.5 × ULN or creatinine clearance < 50 mL/min (calculated
                  according to the Cockcroft-Gault formula, as shown in Annex 2);

               -  Routine urinalysis shows urinary protein of ≥ 2+ or 24-hours urinary protein of ≥
                  1 g;

          7. Uncontrolled malignant ascites (ascites that cannot be controlled by diuretics or
             puncture as judged by the investigator);

          8. Liver metastases accounting for half or more of the total liver volume as determined
             by the investigator;

          9. International normalized ratio (INR) > 1.5 or activated partial thromboplastin time
             (APTT) > 1.5 × ULN;

         10. Clinically significant electrolyte abnormalities as determined by the investigator;

         11. Patients with hypertension that is uncontrollable by medications, defined as: systolic
             blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg;

         12. Patients with poorly controlled diabetes mellitus (fasting blood glucose ≥ CTCAE grade
             2 after regular treatment);

         13. Patients with any disease or condition affecting drug absorption, or patients cannot
             be treated via oral drug administration;

         14. Patients with active gastric and duodenal ulcer, ulcerative colitis and other
             gastrointestinal diseases, active bleeding caused by unresected tumors, or other
             conditions that may lead to gastrointestinal bleeding or perforation as judged by the
             investigator;

         15. With evidence or history of apparent bleeding tendency within 3 months prior to
             randomization (bleeding volume > 30 mL over 3 months, with hematemesis, melena, or
             hematochezia), hemoptysis (> 5 mL of fresh blood over 4 weeks), or history of
             thromboembolism within the past 12 months (including stroke and/or transient ischemic
             attack);

         16. With clinically significant cardiovascular diseases, including but not limited to:
             acute myocardial infarction, severe/unstable angina pectoris or coronary artery bypass
             grafting within 6 months prior to randomization; congestive heart failure of New York
             Heart Association (NYHA) grade > 2; ventricular arrhythmias requiring medication; and
             left ventricular ejection fraction (LVEF) < 50%;

         17. Other malignant tumors in the past 5 five years, except basal cell or squamous cell
             carcinoma that has been treated by radical operation or carcinoma in situ of the
             cervix;

         18. Active or uncontrolled severe infection (≥ CTCAE grade 2) within 2 weeks prior to
             randomization;

         19. Known infection of human immunodeficiency virus (HIV);

         20. Known history of clinically significant liver diseases, including viral hepatitis [for
             known carriers of hepatitis B virus (HBV), the presence of active HBV infection, i.e.,
             positive HBV DNA (> 1 × 104 copies/mL or > 2000 IU/mL), must be excluded; known
             infection of hepatitis C virus (HCV) with positive HCV RNA (> 1 × 103 copies/mL)], or
             other hepatitis or cirrhosis;

         21. Patients with metastasis in the central nervous system (CNS) or previous brain
             metastasis;

         22. Any unresolved toxicity (> CTCAE grade 1) from previous anti-cancer therapy, excluding
             alopecia or neurotoxicity of ≤ grade 2 caused by oxaliplatin;

         23. Patients participated in clinical trials of other investigational drugs which have not
             been approved or marketed in China and received corresponding treatment within 4 weeks
             prior to randomization;

         24. Pregnant (positive pregnancy test before dosing) or breast-feeding women;

         25. Received transfusion therapy, blood products and hematopoietic factors such as albumin
             and granulocyte colony stimulating factor (G-CSF) within 14 days prior to
             randomization;

         26. Received brachytherapy (implantation of radioactive particles) within 60 days before
             the first dose;

         27. Any other diseases with clinically significant metabolic abnormalities, abnormal
             physical observations or abnormal laboratory findings, which are judged by the
             investigator as evidence that the patient has a disease or condition that is
             unsuitable for the study drug (e.g., epileptic seizures requiring treatment), or that
             would interfere with the interpretation of the study results, or that may put the
             patient at a high risk.
      

Gender

All

Ages

18 Years - 75 Years

Accepts Healthy Volunteers

No

Contacts

Rongjun Liu, +86 21 20673222, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT03873532

Organization ID

2017-012-00CH2


Responsible Party

Sponsor

Study Sponsor

Hutchison Medipharma Limited


Study Sponsor

Rongjun Liu, Study Director, Hutchison Medipharma Limited


Verification Date

February 2020