Anlotinib in Combination With PD1 With Gemcitabine Plus(+)Cisplatin for Unresectable or Metastatic Biliary Tract Cancer

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Brief Title

Anlotinib in Combination With PD1 With Gemcitabine Plus(+)Cisplatin for Unresectable or Metastatic Biliary Tract Cancer

Official Title

Anlotinib Hydrochloride in Combination With PD1 With Gemcitabine Plus(+)Cisplatin Compared With Gemcitabine +Cisplatin as First-line Chemotherapy for Unresectable or Metastatic Biliary Tract Cancer: A Randomized, Controlled, Multicenter Phase II Clinical Trial

Brief Summary

      To evaluate the efficacy and safety of Anlotinib Hydrochloride in Combination With PD1 With
      Gemcitabine Plus(+)Cisplatin Compared With Gemcitabine +Cisplatin as First-line Chemotherapy
      for Unresectable or Metastatic Biliary Tract Cancer
    

Detailed Description

      Anlotinib is a multi-target receptor tyrosine kinase inhibitor in domestic research and
      development. It can inhibit the angiogenesis related kinase, such as VEGFR, FGFR, PDGFR, and
      c-Kit kinase.It is a randomized, controlled, multicenter phase II clinical trial conducted in
      China, and plan to recruit 80 patients who were primarily diagnosed with unresectable or
      metastatic biliary tract cancer who have not received previous systemic treatment.To evaluate
      the efficacy and safety of Anlotinib Hydrochloride in Combination With PD1 With Gemcitabine
      Plus(+)Cisplatin Compared With Gemcitabine +Cisplatin as First-line Chemotherapy for
      Unresectable or Metastatic Biliary Tract Cancer.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

12 months OS rate

Secondary Outcome

 Overall Survival (OS)

Condition

Biliary Tract Cancer

Intervention

Anlotinib Hydrochloride in Combination With PD1 With Gemcitabine Plus(+)Cisplatin

Study Arms / Comparison Groups

 Experimental group
Description:  Anlotinib in combination with Sintilimab with Gemcitabine plus(+)Cisplatin

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

80

Start Date

January 1, 2020

Completion Date

January 2022

Primary Completion Date

January 2021

Eligibility Criteria

        Inclusion Criteria:

          1. Patients who are voluntary and sign an informed consent document.

          2. Age between 18-70 years (including 18 and 70), no gender preference.

          3. Expected survival ≥ 12 weeks

          4. ECOG performance status 0 or 1 within 7 days prior to the first dose.

          5. In women of child-bearing age, pregnancy test should be negative within 28 days prior
             to registration, and effective contraception during the treatment period should be
             adopted within 60 days after the last dose. In this trial, women of child-bearing age
             are defined as sexually mature women with: 1) no history of hysterectomy or bilateral
             ovariectomy; 2) natural menopause < continuous 24 months (amenorrhea after cancer
             treatment does not preclude fertility) (i.e., having menstruation at any time within
             preceding continuous 24 months); female spouses of male subjects who are of
             child-bearing age should also follow the above contraceptive requirements.

          6. Adequate organ function.

             Blood test (no blood transfusion, no usage of G-CSF and no medication for correction
             within 14 days prior to screening):

               1. neutrophil count ≥ 1.5×109/L

               2. platelets ≥ 75×109/L

               3. hemoglobin ≥ 90g/L

                  Biochemical test (no albumin transfusion within 14 days prior to screening):

               4. serum creatinine ≤ 1.5× upper limit normal (ULN), or creatinine clearance > 50
                  mL/min;

               5. total bilirubin ≤ 1.5×ULN (total bilirubin ≤ 3× ULN in patients with Gilbert
                  syndrome);

               6. AST and ALT ≤ 2.5× ULN; for patients with hepatic metastases, AST and ALT ≤ 5×
                  ULN;

               7. INR ≤ 2.3 or prothrombin time (PT) exceeding normal control range ≤ 6 seconds;

               8. urine protein < 2+ (if urine protein ≥ 2+, 24-hour urine protein quantitation
                  could be considered, and if 24-hour urine protein quantitation < 1.0g, the
                  patient can be included).

                  Cardiac function:

               9. NYHA < grade 3;

              10. LCEF ≥ 50%;

          7. In patients with active HBV infection: HBV-DNA should < 500 IU/mL (if measured by
             copy/ml, HBV-DNA should <2500 copy/mL); patients should be willing to receive
             antiviral therapy during the treatment period. Patients with positive HCV-DNA should
             receive antiviral therapy according to local guidelines with liver function ≤ CTCAE
             grade 1.

          8. Patients should have adequate nutritional condition, i.e., BMI≥ 18 kg/m2, weight ≥ 40
             kg, and albumin ≥ 3.0 g/dL.

          9. Histologically and/or cytologically-confirmed diagnosis of local advanced or
             metastatic cholangiocarcinoma (including intrahepatic cholangiocarcinoma, extrahepatic
             cholangiocarcinoma and gallbladder carcinoma), which is incurable and unresectable.

         10. Having at least one site of measurable lesion (RECIST Version 1.1). Target lesion of
             tumor progression within previous radiation filed or locally-treated area could be
             considered as measurable.

        Exclusion Criteria:

        Patients who meet any of the following conditions will be excluded from the trial:

          1. Patients who previously received systemic treatment for advanced unresectable or
             metastatic cholangiocarcinoma will be excluded. Neoadjuvant or adjuvant therapy is
             acceptable if treatment is completed at least 6 months prior to randomization and
             shows no progression.

          2. Patients suffering from other active malignancies within 5 years or coexisting with
             cholangiocarcinoma, except adequately treated localized neoplasms including, but not
             limited to: basal cell or squamous cell skin cancer, superficial bladder cancer, in
             situ prostate cancer, in situ cervical cancer, and in situ breast cancer.

          3. Patients who are preparing for or have previously undergone organ or allogenic bone
             marrow transplantation.

          4. Patients with symptomatic moderate or severe ascites requiring paracentesis and
             drainage (except patients with imaging showing mild ascites but no clinical symptoms);
             or patients with uncontrolled or moderate and severe pleural or pericardial effusion.

          5. Patients who have a history of gastrointestinal hemorrhage within preceding 6 months
             or gastrointestinal hemorrhagic tendency, e.g., esophagogastric varices with a risk of
             hemorrhage, active peptic ulcer, fecal occult blood being continuously positive (if
             fecal occult blood is positive at baseline, reexamination can be considered; if
             reexamination is still positive, esophagogastroduodenoscopy (EGD) should be
             considered; if EGD indicates esophagogastric varices with a risk of hemorrhage, then
             the patient will be excluded).

          6. Patients with hereditary or acquired bleeding tendency (e.g., coagulation dysfunction)
             or thrombophilia, e.g., hemophilia patients; or patients who are currently receiving
             or recently received (within preceding 10 days) full-dose anticoagulant or
             thrombolytic agents orally or by injection for therapeutic purposes (prophylactic
             usage of low-dose aspirin or low molecular heparin is acceptable).

          7. Patients who are receiving or recently received (within preceding 10days) aspirin
             (>325 mg/d (maximum antiplatelet dose)) or dipyridamole, ticlopidine, clopidogrel and
             cilostazol.

          8. Patients who have a history of thrombosis or embolism within preceding 6 months,
             including cerebrovascular events (transient ischemic attack, cerebral hemorrhage and
             cerebral infraction) and pulmonary embolism.

          9. Patients with uncontrolled heart disease or relevant symptoms, e.g., (1) heart failure
             with NYHA > 2 (Appendix 5) or UCG showing LVEF <50%; (2) unstable angina; (3) a
             history of myocardial infraction within preceding 1 year; (4) supraventricular or
             ventricular arrhythmia with clinical significance indicating treatment or
             intervention; (5) QTc > 450ms (male); QTc > 470ms(female) (QTc is calculated by
             Fridericia law; if QTc is abnormal, it can be continuously measured 3 times with an
             interval of 2 minutes, taking the average).

         10. Patients with hypertension uncontrolled by drug or treatment (SBP≥140 mmHg or DBP≥90
             mmHg) (based on≥2 measurements and taking average); or patients with a history of
             hypertensive emergency or hypertensive encephalopathy.

         11. Patients who have severe vascular diseases (e.g., aortic aneurysm requiring surgical
             repair or with recent peripheral arterial thrombosis) within preceding 6 months.

         12. Patients with severe, unhealed or open wounds, and active ulcers or untreated
             fractures.

         13. Patients who received major operation (except diagnosis) within preceding 4 weeks, or
             who are expected to receive major operation during the trial period.

         14. Patients who are unable to swallow tablets, or with malabsorption syndrome or any
             condition that may affect gastrointestinal absorption.

         15. Patients with aeroperitoneum that cannot be explained by puncture or recent surgery.

         16. Patients with brain metastases before or at present

         17. Patients suffering from uncontrolled systemic diseases including, but not limited to:
             diabetes, hypertension, pulmonary fibrosis, acute pulmonary disease, interstitial lung
             disease, cirrhosis, angina and severe arrhythmia.

         18. Patients suffering from interstitial pneumonia or ILD, or with a history of
             interstitial pneumonia or ILD requiring hormone therapy, or with other pulmonary
             fibrosis,organic pneumonia(e.g., obliterative bronchiolitis), pneumoconiosis,
             drug-induced pneumonia and idiopathic pneumonia that may interfere with the diagnosis
             and management of immune-related pulmonary toxicity; or patients with CT image
             indicating active pneumonia or severely impaired pulmonary function during screening.
             Radiation pneumonia is acceptable in the radiation field. Patients with active
             tuberculosis will be excluded.

         19. Patients suffering from active autoimmune disease or with a history of autoimmune
             disease that may recur (including, but not limited to: autoimmune hepatitis,
             interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis,
             hyperthyroidism and hypothyroidism [patients controlled only by hormone replacement
             therapy are acceptable]) will be excluded; patients with dermatosis requiring no
             systemic treatment, including vitiligo, psoriasis and alopecia, are acceptable;
             patients win T1DM controlled by insulin therapy, or patients with completely-relieved
             childhood asthma requiring no intervention in adulthood are acceptable; patients with
             asthma requiring bronchodilator intervention will be excluded.

         20. Patients who received immunosuppressive drug or systemic hormone therapy to achieve
             immunosuppression (prednisone>10mg/d or hormones of equivalent effects) within
             preceding 14 days.

         21. Patients who received strong CYP3A4/CYP2C19 inducer including rifampin (and its
             analogs) and hypericum perforatum or strong CYP3A4/CYP2C19 inhibitor within preceding
             14 days.

         22. Patients who have a history of severe allergies to any monoclonal antibody or
             anti-angiogenic targeted drugs.

         23. Patients who had severe infection within preceding 4 weeks including, but not limited
             to: infection, bacteremia and complications of severe pneumonia resulting in
             hospitalization; or patients who received therapeutic antibiotics orally or
             intravenously within preceding 2 weeks (prophylactic usage of antibiotics [e.g.,
             prevention of urinary tract infection or exacerbation of COPD] is acceptable).

         24. Patients with innate or acquired immunodeficiency (e.g., patients infected with HIV)

         25. Patients who previously received anti-PD-1 therapy or other immunotherapies targeting
             PD-1/PD-L1, or tyrosine kinase inhibitor therapy.

         26. Palliative radiotherapy for non-target lesions to control symptoms is acceptable, but
             should be completed at least 2 weeks prior with adverse events not recovering to
             ≤CTCAE grade 1

         27. Patients who received attenuated live vaccine within preceding 28 day, or who are
             expected to receive the vaccine during sintilimab treatment or within 60 days after
             the last dose of sintilimab.

         28. Patients who received anti-tumor cytotoxic chemotherapy, biotherapy (e.g., monoclonal
             antibody), immunotherapy (e.g., IL-2 or interferon) or other investigational drugs
             within 4 weeks prior to registration.

         29. Patients with other factors that may affect the outcomes or lead to withdrawal (judged
             by the researcher), including alcohol abuse, drug abuse, other serious disease
             (including mental illness) requiring combined treatment, significantly abnormal
             laboratory test index, and family or society factors that may affect patient safety.

         30. Patients who previously received antitumor therapy and prior toxicity has not
             recovered to CTCAE grade 0-1, aside from the following conditions:

               1. alopecia;

               2. hyperpigmentation;

               3. peripheral neurotoxicity recovered to < CTCAE grade 2;

               4. long-term toxicity caused by radiotherapy cannot recover (judged by the
                  researcher).

         31. Patients who have active tuberculosis(TB) and are receiving anti-TB therapy, or who
             received anti-TB therapy within 1 year prior to screening.

         32. Patients who are pregnant or lactating. -
      

Gender

All

Ages

18 Years - 70 Years

Accepts Healthy Volunteers

No

Contacts

Jieer Ying, 18258255285, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT04300959

Organization ID

ALTNZJ-004


Responsible Party

Sponsor

Study Sponsor

Zhejiang Cancer Hospital


Study Sponsor

Jieer Ying, Principal Investigator, Zhejiang Cancer Hospital


Verification Date

March 2020