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Biliary Tract MalignanciesPhase 1NCT06181032

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

A Phase 1 study testing Adebrelimab, Apatinib and Gemcitabine in people with Biliary Tract Malignancies, run by First Affiliated Hospital of Fujian Medical University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Biliary Tract Malignancies
What is being tested?
Adebrelimab, Apatinib and Gemcitabine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
1 siteChina
Study dates
23 Dec 2023to 23 Feb 2029
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • (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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Zhibo Zhang contact

13960986516

zbzhang_1234@163.com

China1 site, 1 recruiting

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian, 350000

    Zhang Zhibo, PhD, 008618559853003, wql0211@gmail.com

    Recruiting

Other trials in China

About this study

Official title: A Single-arm Prospective Clinical Study of Adebrelimab in Combination With Apatinib Gemcitabine and Cisplatin for the Neoadjuvant Treatment of Biliary Tract Malignancies

Evaluating the efficacy and safety of adebrelimab in combination with apatinib, gemcitabine and cisplatin in the neoadjuvant treatment of patients with biliary tract malignancies.

Read the detailed description

Existing immune-combination chemotherapy has shown excellent data in advanced biliary malignancies, so what is the efficacy and safety of this regimen in neoadjuvant therapy? Moreover, the current combination model of immunization combined with anti-angiogenic drugs has become another new direction in the field of solid tumor treatment. Therefore, our group designed a single-arm, prospective clinical study of adebrelimab in combination with apatinib, gemcitabine and cisplatin in the neoadjuvant treatment of biliary malignancies, aiming at evaluating the efficacy and safety of adebrelimab in combination with apatinib, gemcitabine and cisplatin in the neoadjuvant treatment of biliary malignancies in patients with a view to bringing longer-term benefits to patients with resectable biliary malignancies.

Being tested
Adebrelimab, Apatinib, Gemcitabine, Cisplatin
Keywords
biliary tract malignancies, neoadjuvant treatment, adebrelimab, apatinib, gemcitabine and cisplatin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AdebrelimabDrug

    Also called SHR-1316

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

  • ApatinibDrug

    Apatinib: 250 mg, po, QD, Q3W;

  • GemcitabineDrug

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

  • CisplatinDrug

    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.

Study groups in NCT06181032
Study groupRoleWhat they receive
Single armExperimentalNeoadjuvant treatment with adebrelimab in combination with apatinib gemcitabine and cisplatin
Receives: Drug: Adebrelimab; Drug: Apatinib; Drug: Gemcitabine; Drug: Cisplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Relapse free survival（RFS）

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

    Measured: 3 years

  2. 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.

    Measured: 3 years

Secondary outcomes (7)

  1. Pathological complete response rate (pCR)

    Rate of residual tumor cells not detected by pathology in excised tissue samples.

    Measured: Within one week after surgery

  2. Major pathological response rate (MPR)

    The percentage of active tumor cells in excised tissue samples is less than 10% of the rate.

    Measured: Within one week after surgery

  3. surgery rate

    Proportion of patients with final surgical resection among enrolled surgically resectable patients.

    Measured: Within one week after surgery

  4. Radical (R0) resection rate

    No residual cancer cells on the margins

    Measured: Within one week after surgery

  5. Objective response rate (ORR)

    Refers to the proportion of all subjects with a best overall result (BOR) of complete remission (CR) or partial remission (PR) as rated according to RECIST 1.1 criteria. If efficacy of CR or PR is achieved, subjects must be confirmed not less than 4 weeks ± 7 days after the initial evaluation.

    Measured: Within 2 weeks prior to surgery

  6. Disease control rate (DCR)

    Refers to the proportion of all subjects with a best overall result (BOR) of complete remission (CR), partial remission (PR), and stable disease (SD) as rated according to RECIST 1.1 criteria.

    Measured: Within 2 weeks prior to surgery

  7. Overall survival (OS)

    Defined as the time between the date of first dose and the death of the subject due to all causes. Subjects who were alive at the last follow-up visit had OS counted as data censored at the time of the last follow-up visit. The OS of subjects who were lost to follow-up was counted as data censored at the time of last confirmed survival prior to the lost follow-up. OS for data censoring was defined as the time from first dose to censoring.

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Dec 2023
  2. Study start23 Dec 2023
  3. Primary completion23 Feb 2029 (estimated)
  4. Study completion23 Feb 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
35 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06181032
Sponsor's protocol ID
23-OBU-FJ-BTC-II-001
Status last verified
Apr 2024
First submitted
23 Nov 2023
Last updated
30 Apr 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Adebrelimab, Apatinib and Gemcitabine in people with Biliary Tract Malignancies, run by First Affiliated Hospital of Fujian Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 25 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Zhibo Zhang (13960986516, zbzhang_1234@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Relapse free survival（RFS） (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06181032.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2024.

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