A Study of Adebrelimab in Combination With Apatinib Gemcitabine and Cisplatin in Biliary Tract Malignancies

NCT06181032 | Recruiting Phase 1

• 1 other identifier: 23-OBU-FJ-BTC-II-001
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Biliary Tract Malignancies

Keywords

biliary tract malignancies; neoadjuvant treatment; adebrelimab; apatinib; gemcitabine and cisplatin

Outcome Measures

Primary Outcomes (2)

• Relapse free survival（RFS）

  Means the time from the date of the curative surgery to the date of relapse or death.

  3 years

• AE

  Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

  3 years

Secondary Outcomes (7)

• Pathological complete response rate (pCR)

  Within one week after surgery

• Major pathological response rate (MPR)

  Within one week after surgery

• surgery rate

  Within one week after surgery

• Radical (R0) resection rate

  Within one week after surgery

• Objective response rate (ORR)

  Within 2 weeks prior to surgery

Study Arms (1)

Single arm

EXPERIMENTAL

Neoadjuvant treatment with adebrelimab in combination with apatinib gemcitabine and cisplatin

Drug: Adebrelimab; Drug: Apatinib; Drug: Gemcitabine; Drug: Cisplatin

Interventions

Adebrelimab DRUG

Adebrelimab: 1200mg or 20mg/kg, iv, D1, Q3W;

Also known as: SHR-1316

Single arm

Apatinib DRUG

Apatinib: 250 mg, po, QD, Q3W;

Single arm

Gemcitabine DRUG

Gemcitabine: 1000 mg/m2, iv, 30min, D1, D8, Q3W;

Single arm

Cisplatin DRUG

Cisplatin: 25 mg/m2, iv, 30min, D1, D8, Q3W; Injection sequence: adebelizumab → gemcitabine → cisplatin (sequential interval of at least 30 min), 3 cycles of neoadjuvant therapy.

Single arm

Eligibility Criteria

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

You may qualify if:

• \. Age: 18 years old ≤ 75 years old, both male and female.
• \. Patients with gallbladder cancer or cholangiocarcinoma (intrahepatic or extrahepatic) diagnosed by histologic or cytologic examination.
• \. 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).
• \. 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.
• \. 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).
• \. ECOG PS score of 0-1.
• \. Expected survival ≥ 12 weeks.
• \. 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)

You may not qualify if:

• \. Pregnant or lactating women.
• \. 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).
• \. Patients with impaired consciousness or inability to cooperate with treatment, or patients with combined mental illness.
• \. Patients who have participated in other clinical trials in the last three months.
• \. Patients who have received other PD-1, PD-L1, CTLA-4 inhibitors in the past.
• \. 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.
• \. Use of interferon or systemic hormone therapy for immunosuppression within 14 days prior to enrollment (dose \>10mg/day prednisone or other equipotent hormone).
• \. 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.
• \. Bleeding from ruptured esophageal (fundus) varices within 1 month prior to treatment.
• \. 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).
• \. Intractable large amount of ascites and pleural fluid, malaise.
• \. Severe liver, kidney, heart, lung, brain and other major organ failure.
• \. 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).
• \. 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%.
• \. Patients with positive urine protein (urine protein test of 2+ or more, or 24-hour urine protein quantification \>1.0g).

Sponsors & Collaborators

• First Affiliated Hospital of Fujian Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, 350000, China

RECRUITING

MeSH Terms

Interventions

apatinib; Gemcitabine; Cisplatin

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Yufeng Chen

  Zhangzhou Hospital of Fujian Medical University

  PRINCIPAL INVESTIGATOR

• Maolin Yan

  Fujian Provincial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhibo Zhang

CONTACT

13960986516; zbzhang_1234@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Hepatobiliary and Pancreatic Surgery Department

Study Record Dates

• First Submitted: November 23, 2023
• First Posted: December 26, 2023
• Study Start: December 23, 2023
• Primary Completion (Estimated): February 23, 2029
• Study Completion (Estimated): February 23, 2029
• Last Updated: April 30, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)