PD-1 Inhibitor Sintilimab Combined With Capecitabine for Adjuvant Treatment After Radical Resection of Cholangiocarcinoma.

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Brief Title

PD-1 Inhibitor Sintilimab Combined With Capecitabine for Adjuvant Treatment After Radical Resection of Cholangiocarcinoma.

Official Title

Henan Cancer Hospital, Affiliated Cancer Hospital of Zhengzhou University.

Brief Summary

      This is a single-center, single-arm, prospective phase II clinical study to evaluate the
      effectiveness and safety of Sintilimab combined with capecitabine in patients after radical
      resection of cholangiocarcinoma.

      The primary endpoint of the study:

      • 2-year recurrence-free survival rate

      Secondary endpoint:

      • Overall survival (OS), 1y RFS%, 2y OS%, 3y OS%, time to recurrence (TTR), RFS;Safety and
      tolerability.

      Study drugs, dosages, and methods of administration:

        -  Sintilizumab, 200 mg, intravenous infusion, a treatment cycle every 3 weeks,
           administration on the first day of each cycle, 6 cycles.

        -  Capecitabine: 1250 mg/m2, orally, twice a day, 1-14 days, one treatment cycle every
           three weeks, 8 cycles.
    


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

2y RFS%

Secondary Outcome

 OS

Condition

Cholangiocarcinoma

Intervention

Sintilimab

Study Arms / Comparison Groups

 GROUP 1
Description:  Sintilizumab, 200 mg, intravenous infusion, a treatment cycle every 3 weeks, administration on the first day of each cycle, 6 cycles.
Capecitabine: 1250 mg/m2, orally, twice a day, 1-14 days, one treatment cycle every three weeks, 8 cycles.

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

73

Start Date

January 2022

Completion Date

December 2024

Primary Completion Date

December 2023

Eligibility Criteria

        Inclusion Criteria:

          1. Be between 18-75 years old;

          2. Sign written informed consent, and be able to comply with the visits and related
             procedures stipulated in the plan;

          3. Histopathological diagnosis was extrahepatic cholangiocarcinoma, including hilar
             cholangiocarcinoma and distal cholangiocarcinoma, and had undergone radical resection;

          4. The pathology report of the patient must confirm complete resection (recovery from the
             operation to be disease-free, and the sample has negative margins R0, R1);

          5. The patient must be treated within 12 weeks after the radical resection;

          6. No anti-tumor treatment before radical resection, including radiotherapy and
             chemotherapy, targeted therapy and immunotherapy;

          7. ECOG score 0-1 points;

          8. Expected survival time> 6 months;

          9. With sufficient organ and bone marrow function, the laboratory test values within 7
             days before randomization meet the following requirements (no blood components, cell
             growth factors, albumin and other corrective treatment drugs are allowed to meet the
             conditions), as follows :1) Blood routine: absolute neutrophil count (ANC) ≥1.5×109/L;
             platelet count (platelet, PLT) ≥75×10 9/L; hemoglobin content (hemoglobin, HGB) ≥9.0 g
             /dL;2) Liver function: serum total bilirubin (TBIL) ≤ 2×upper limit of normal value
             (ULN); alanine aminotransferase (ALT) and aspartate amino transfer Enzyme (aspartate
             transferase, AST) ≤5×ULN; serum albumin ≥28 g/L; alkaline phosphatase (alkaline
             phosphatase, ALP) ≤5×ULN;3) Renal function: serum creatinine (Cr) ≤ 1.5×ULN or
             creatinine clearance (clearance of creatinine, CCr) ≥ 50 mL/min (Cockcroft-Gault
             formula); urine routine results show urine protein <2+; against baseline For patients
             whose urine protein is ≥2+ by routine urine test, 24-hour urine collection and 24-hour
             urine protein quantitative <1g should be performed;4) Coagulation function:
             International normalized ratio (INR) and activated partial thromboplastin time (APTT)
             ≤ 1.5 times ULN.

         10. Female patients of childbearing age or male patients whose sexual partners are females
             of childbearing age should take effective contraceptive measures throughout the
             treatment period and 6 months after the last treatment.

        Exclusion Criteria:

          1. Diagnosis of other malignant diseases outside the biliary tract within 5 years before
             the first administration (excluding radically cured skin basal cell carcinoma, skin
             squamous cell carcinoma, and/or radically excised carcinoma in situ);

          2. Currently participating in interventional clinical research treatment, or received
             other research drugs or used research devices within 4 weeks before the first
             administration;

          3. Have received the following therapies in the past: anti-PD-1, anti-PD-L1 or anti-PD-L2
             drugs or for another stimulating or synergistic inhibition of T cell receptors (for
             example, CTLA-4, OX-40, CD137) drug;

          4. Have received radiotherapy for biliary tract tumors in the past;

          5. Received Chinese patent medicines with anti-tumor indications or immunomodulatory
             drugs (including thymosin, interferon, interleukin, except for local use to control
             pleural effusion) systemic systemic treatment within 2 weeks before the first
             administration;

          6. An active autoimmune disease that requires systemic treatment (such as the use of
             disease-relieving drugs, glucocorticoids, or immunosuppressive agents) occurred within
             2 years before the first administration. Alternative therapies (such as thyroxine,
             insulin, or physiological glucocorticoids for adrenal or pituitary insufficiency) are
             not considered systemic treatments. Known history of primary immunodeficiency. Only
             patients with positive autoimmune antibodies need to confirm whether there are
             autoimmune diseases based on the judgment of the investigator;

          7. Are receiving systemic glucocorticoid therapy (excluding nasal spray, inhaled or other
             local glucocorticoids) or any other form of immunosuppressive therapy within 4 weeks
             before the first administration of the study. Note: Physiological doses of
             glucocorticoids are allowed (≤10 mg/day prednisone or equivalent drugs);

          8. There is clinically uncontrollable pleural effusion/abdominal effusion (patients who
             do not need to drain the effusion or stop drainage for 3 days without a significant
             increase in effusion can be included in the group)

          9. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic
             hematopoietic stem cell transplantation

         10. Those who are known to be allergic to the active ingredients or excipients of
             Sintilimab

         11. Before starting treatment, have not fully recovered from toxicity and/or complications
             caused by any intervention (ie, ≤ Grade 1 or reached baseline, excluding fatigue or
             hair loss)

         12. Known history of human immunodeficiency virus (HIV) infection (ie HIV 1/2 antibody
             positive)

         13. Untreated active hepatitis B (defined as HBsAg positive and the number of copies of
             HBV-DNA detected at the same time is greater than the upper limit of normal value of
             the laboratory department of the research center).Note: Hepatitis B subjects who meet
             the following criteria can also be included in the group:1) The HBV viral load before
             the first administration is less than 2.5×103 copies/ml (500 IU/ml), and the subject
             should receive anti-HBV treatment during the entire study treatment period;2) For
             subjects with anti-HBc (+), HBsAg (-), anti-HBs (-) and HBV viral load (-), there is
             no need to receive preventive anti-HBV treatment, but close monitoring of virus
             reactivation is required.

         14. Active HCV infected subjects (HCV antibody-positive and HCV-RNA level is higher than
             the lower limit of detection);

         15. Have received a live attenuated vaccine within 4 weeks before the first dose;

         16. Pregnant or lactating women;

         17. There are any serious or uncontrollable systemic diseases, such as:1) The resting
             electrocardiogram has major abnormalities in rhythm, conduction, or morphology that
             are severe and difficult to control, such as complete left bundle branch block, heart
             block above Ⅱ degree, ventricular arrhythmia or atrial fibrillation;2) Unstable angina
             pectoris, congestive heart failure, chronic heart failure of New York Heart
             Association (NYHA) grade ≥ 2;3) Any arterial thrombosis, embolism or ischemia, such as
             myocardial infarction, unstable angina, cerebrovascular accident or transient ischemic
             attack, occurred within 6 months before being selected for treatment;4) Major surgery
             (craniotomy, thoracotomy or laparotomy) or unhealed wounds, ulcers or fractures have
             been received within 4 weeks before the first administration. Have received tissue
             biopsy or other minor surgical procedures within 7 days before the first
             administration, except for venipuncture catheters for the purpose of intravenous
             infusion;5) Unsatisfactory blood pressure control (systolic blood pressure>140 mmHg,
             diastolic blood pressure>90 mmHg);6) Active tuberculosis;7) There is an active or
             uncontrolled infection that requires systemic treatment;8) There is clinically active
             diverticulitis, abdominal abscess, gastrointestinal obstruction;9) Liver diseases such
             as cirrhosis, decompensated liver disease, acute or chronic active hepatitis;10) Poor
             control of diabetes (fasting blood glucose (FBG)> 10mmol/L);11) Urine routine test
             shows urine protein ≥++, and the 24-hour urine protein quantitative is confirmed to be
             >1.0 g;12) Patients with mental disorders who cannot cooperate with treatment;

         18. The medical history or disease evidence, abnormal treatment or laboratory test values
             that may interfere with the test results, prevent the subject from participating in
             the study, or the investigator believes that it is not suitable for inclusion in the
             group. The investigator believes that there are other potential risks and is not
             suitable for participation.
      

Gender

All

Ages

18 Years - 75 Years

Accepts Healthy Volunteers

No

Contacts

Jinxue Zhou, MD, 13837175001, [email protected]



Administrative Informations


NCT ID

NCT05207735

Organization ID

2021-246


Responsible Party

Sponsor

Study Sponsor

Henan Cancer Hospital


Study Sponsor

Jinxue Zhou, MD, Study Chair, Henan cancer hospital,affiliated cancer hospital of zhengzhou university


Verification Date

November 2021