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

NCT05207735 | Unknown Phase 2

• 1 other identifier: 2021-246
• Study Type: interventional
• Target: 73
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cholangiocarcinoma

Keywords

PD-1 Inhibitor; Capecitabine; Adjuvant Treatment

Outcome Measures

Primary Outcomes (1)

• 2y RFS%

  2-year recurrence-free survival rate

  up to 24 months

Secondary Outcomes (6)

• OS

  up to 36 months

• 1y RFS%

  up to 12 months

• 2y OS%

  up to 24 months

• 3y OS%

  up to 36 months

• TTR

  up to 36 months

Study Arms (1)

GROUP 1

EXPERIMENTAL

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.

Drug: Sintilimab

Interventions

Sintilimab DRUG

* 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.

Also known as: Capecitabine

GROUP 1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be between 18-75 years old;
• Sign written informed consent, and be able to comply with the visits and related procedures stipulated in the plan;
• Histopathological diagnosis was extrahepatic cholangiocarcinoma, including hilar cholangiocarcinoma and distal cholangiocarcinoma, and had undergone radical resection;
• 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);
• The patient must be treated within 12 weeks after the radical resection;
• No anti-tumor treatment before radical resection, including radiotherapy and chemotherapy, targeted therapy and immunotherapy;
• ECOG score 0-1 points;
• Expected survival time\> 6 months;
• 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.
• 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.

You may not qualify if:

• 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);
• Currently participating in interventional clinical research treatment, or received other research drugs or used research devices within 4 weeks before the first administration;
• 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;
• Have received radiotherapy for biliary tract tumors in the past;
• 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;
• 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;
• 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);
• 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)
• Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation
• Those who are known to be allergic to the active ingredients or excipients of Sintilimab
• 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)
• Known history of human immunodeficiency virus (HIV) infection (ie HIV 1/2 antibody positive)
• 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.
• Active HCV infected subjects (HCV antibody-positive and HCV-RNA level is higher than the lower limit of detection);
• Have received a live attenuated vaccine within 4 weeks before the first dose;

Sponsors & Collaborators

• Henan Cancer Hospital: lead

MeSH Terms

Conditions

Cholangiocarcinoma

Interventions

sintilimab; Capecitabine

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Jinxue Zhou, MD

  Henan cancer hospital,affiliated cancer hospital of zhengzhou university

  STUDY CHAIR

Central Study Contacts

Jinxue Zhou, MD

CONTACT

13837175001; zhoujx888@126.com

Zhengzheng Wang, MD

CONTACT

13526638243; wangzz818@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2021
• First Posted: January 26, 2022
• Study Start: January 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2024
• Last Updated: January 26, 2022

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share