Overview
A Study of Adebrelimab in Combination With Apatinib Gemcitabine and Cisplatin in Biliary Tract Malignancies
Status:
Recruiting
Recruiting
Trial end date:
2029-02-23
2029-02-23
Target enrollment:
0
0
Participant gender:
All
All
Summary
Evaluating the efficacy and safety of adebrelimab in combination with apatinib, gemcitabine and cisplatin in the neoadjuvant treatment of patients with biliary tract malignancies.Phase:
Phase 1Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
First Affiliated Hospital of Fujian Medical UniversityTreatments:
Apatinib
Gemcitabine
Criteria
Inclusion Criteria:- 1. Age: 18 years old ≤ 75 years old, both male and female.
- 2. Patients with gallbladder cancer or cholangiocarcinoma (intrahepatic or
extrahepatic) diagnosed by histologic or cytologic examination.
- 3. high-quality cross-sectional imaging by computed tomography (CT) or magnetic
resonance imaging (MRI) with a diagnosis of surgically resectable high-risk biliary
malignancy limited to the liver, bile ducts, and/or regional lymph nodes. (Must meet
at least one of the following criteria)
- (1) T-grade ≥ Ib (Ib-IV);
- (2) Single lesion > 5 cm;
- (3) Multifocal tumors or satellite lesions confined to the same hepatic lobe as the
primary lesion but still technically resectable;
- (4) Presence of major vascular invasion but still technically resectable;
- (5) Suspected or involved regional lymph nodes (N1);
- (6) No distant extrahepatic disease (M0).
- 4. Patients who have not received previous systemic therapy and who, in the judgment
of the physician, have no contraindications to surgery, and the patient agrees to
undergo radical surgical treatment.
- 5. At least one measurable lesion (according to the RECIST 1.1 criteria requires that
the measurable lesion be ≥10 mm in long diameter on spiral CT scan or ≥15 mm in short
diameter in malignant lymph nodes).
- 6. ECOG PS score of 0-1.
- 7. Expected survival ≥ 12 weeks.
- 8. Normal function of major organs and fulfillment of the following criteria:
- (1) Criteria for routine blood tests need to be met: (no blood transfusion within 14
days)
- a. Hemoglobin (HB) ≥ 90g/L;
- b. White blood cell count (WBC) ≥3×109/L;
- c. Absolute neutrophil count (ANC) ≥ 1.5 x 109/L;
- d. Platelet (PLT) ≥80×109/L.
- (2) Biochemical tests need to meet the following criteria:
- a. Bilirubin (BIL) <1.5 times the upper limit of normal (ULN);
- b. Glutamine aminotransferase (ALT) and glutamine aminotransferase AST <5 ULN;
- c. serum creatinine (Cr) ≤ 1.5 ULN.
- 9. Women of childbearing potential must have a negative pregnancy test (serum) or
urine HCG test within 7 days prior to enrollment and be willing to use an appropriate
method of contraception for the duration of the trial and for 8 weeks after the last
administration of the test drug; in the case of males, they should be surgically
sterilized or agree to use an appropriate method of contraception for the duration of
the trial and for 8 weeks after the last administration of the test drug.
- 10. Subjects voluntarily enroll in the study, have good compliance, and cooperate with
follow-up visits.
Exclusion Criteria:
- 1. Pregnant or lactating women.
- 2. Patients with autoimmune diseases, organ/hematopoietic stem cell transplantation or
other malignant tumors (except cured basal cell carcinoma of the skin and cervical
carcinoma in situ).
- 3. Patients with impaired consciousness or inability to cooperate with treatment, or
patients with combined mental illness.
- 4. Patients who have participated in other clinical trials in the last three months.
- 5. Patients who have received other PD-1, PD-L1, CTLA-4 inhibitors in the past.
- 6. Patients who have undergone major surgery or chemotherapy or other systemic or
localized treatments (including but not limited to radiation therapy, ablation
therapy, etc.) for the target lesion prior to enrollment.
- 7. Use of interferon or systemic hormone therapy for immunosuppression within 14 days
prior to enrollment (dose >10mg/day prednisone or other equipotent hormone).
- 8. Prior hypersensitivity to PD-1, PD-L1, CTLA-4 monoclonal antibody, any component of
a chemotherapeutic agent, or other drugs of the same type used in the trial.
- 9. Bleeding from ruptured esophageal (fundus) varices within 1 month prior to
treatment.
- 10. Uncorrectable coagulation dysfunction and serious blood abnormalities with severe
bleeding tendency. Platelet count <50×109/L and severe coagulation abnormality cannot
withstand surgery (anticoagulation therapy and/or anticoagulant application should be
discontinued for more than 1 week before radiation therapy).
- 11. Intractable large amount of ascites and pleural fluid, malaise.
- 12. Severe liver, kidney, heart, lung, brain and other major organ failure.
- 13. Suffer from high blood pressure which cannot be reduced to normal range by
antihypertensive drugs (systolic blood pressure > 140 mmHg, diastolic blood pressure >
90 mmHg).
- 14. Previous severe cardiovascular disease, including but not limited to the
following: myocardial ischemia or myocardial infarction of grade II or above, poorly
controlled arrhythmia (including QTc interval ≥450 ms for men and ≥470 ms for women);
cardiac insufficiency of grades Ⅲ to Ⅳ according to the NYHA standard or cardiac
ultrasound suggesting that the left ventricular ejection fraction (LVEF) is <50%.
- 15. Patients with positive urine protein (urine protein test of 2+ or more, or 24-hour
urine protein quantification >1.0g).
- 16. Inability to swallow tablets, malabsorption syndrome, or any condition that
interferes with gastrointestinal absorption.
- 17. Patients with other serious concomitant conditions that, in the judgment of the
investigator, jeopardize patient safety or interfere with the patient's ability to
complete the study.