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Unresectable Biliary Tract CarcinomaPhase 2NCT06749730

Adebrelimab Combined with Apatinib and Gemcitabine and Cisplatin (GP) First-line Treatment for Unresectable Biliary Tract Carcinoma

A Phase 2 study testing Adebrelimab, Apatinib and gemcitabine and cisplatin in people with Unresectable Biliary Tract Carcinoma, run by Henan Cancer Hospital 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
Search all trials

Trial summary

This study is designed to combine anti-angiogenic drugs on the basis of PD-L1+ gemcitabine/cisplatin, hoping to further improve the curative effect of advanced BTC treatment and provide more choices for first-line treatment of BTC in China. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Unresectable Biliary Tract Carcinoma
What is being tested?
Adebrelimab, Apatinib and gemcitabine and cisplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
63 participants
Where
1 siteChina
Study dates
1 Apr 2024to Jun 2027
Phase
Phase 2
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1.Age range from 18 to 80 years old, regardless of gender;
  • 2.Histologically confirmed, unresectable advanced or metastatic BTC including cholangiocarcinoma (intrahepatic or extrahepatic), gallbladder carcinoma.
  • 3. Patients who have not received systematic treatment for BTC in the past .
  • 4.At least one measurable lesion (according to RECIST v1.1 requirements).
  • 5.ECOG PS: 0-1 points;
  • 6.Expected survival time ≥ 12 weeks;
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  • 7. The main organs are functioning normally and meet the following requirements White blood cell count ≥ 3.0× 10 9/L; Hb ≥ 90 g/l; Absolute neutrophil count ≥ 1.5× 10 9/L; Platelet count ≥ 100× 10 9/L; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)≤ 2.5 times the upper limit of normal limit (ULN); Total bilirubin ≤ 2 times of ≤ULN; Serum creatinine ≤ 1.5 times of ≤ULN; Albumin ≥ 30 g/l;
  • 8. Women of childbearing age must undergo a pregnancy test (serum or urine) with a negative result within 14 days prior to enrollment, and voluntarily use appropriate methods of contraception during observation and within 8 weeks after the last administration of study medication; For males, surgical sterilization should be performed, or appropriate methods of contraception should be agreed upon during observation and within 8 weeks after the last administration of study medication;
  • 9. The subjects voluntarily joined this study, signed an informed consent form, and cooperated with follow-up.

Who cannot join

  • 1. Histologically diagnosed as neuroendocrine carcinoma;
  • 2. People who are allergic to adebelizumab, apatinib, gemcitabine, cisplatin or their auxiliary materials;
  • 3. Systemic treatment in the past;
  • 4. Pleural effusion, pericardial effusion or ascites accompanied by clinical symptoms and judged by the researcher to require frequent drainage;
  • 5. History of organ transplantation (including autologous bone marrow transplantation and peripheral stem cell transplantation);
  • 6. Active or uncontrollable serious infection (≥ CTCAE grade 5.02 infection), including but not limited to hospitalization due to infection complications, bacteremia or severe pneumonia, and unexplained fever > 38.5℃ before the first administration;
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  • 7. Liver cirrhosis and active hepatitis; Hepatitis B reference: HBsAg positive, and HBV DNA exceeds the upper limit of normal value (1000 copies /ml or 500 IU/ml); Patients with hepatitis B virus (HBV) infection or cured HBV infection in the past (defined as the existence of hepatitis B core antibody [HBcAb] and the absence of HBsAg, and those with normal HBV DNA value during the screening period can be included; Hepatitis C reference: HCV antibody is positive, and the detection value of HCV virus titer exceeds the upper limit of normal value /HCV RNA or HCV Ab detection indicates acute and chronic infection;
  • 8. Those who have a history of psychotropic drug abuse and cannot quit or have mental disorders;
  • 9.Within 5 years, the subject has other malignant tumors in the past or at the same time and needs active treatment (except for fully treated basal cell or squamous cell skin cancer, cervical carcinoma in situ and breast cancer in situ, if the estimated 5-year survival rate is more than 90%);
  • 10. There is an uncorrectable coagulation disorder;
  • 11. Severe liver diseases (such as liver cirrhosis), kidney diseases, respiratory diseases, uncontrollable diabetes or other types of systemic diseases.
  • 12. Patients whose imaging shows that the tumor has invaded important blood vessels or who are judged by the researchers to be very likely to invade important blood vessels and cause fatal bleeding during the follow-up study;
  • 13. Active autoimmune disease or immunodeficiency, or the following medical history, including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, rheumatoid arthritis, inflammatory bowel disease, hypophysitis, vasculitis, nephritis, etc.) shall not be included. The following exceptions are made: patients with a history of autoimmune hypothyroidism but receiving thyroid hormone replacement therapy can be included in the study. Patients with type 1 diabetes whose blood sugar has been controlled after insulin administration can participate in this study.
  • 14, Within 14 days prior to signing the informed consent form, use immunosuppressive agents or systemic hormone therapy to achieve immunosuppressive effects (dose>10mg/day prednisone or other therapeutic hormones)
  • 15.Arterial/venous thrombosis events occurred within 6 months before the first administration, such as cerebrovascular accident (including temporary ischemic attack, cerebral hemorrhage, cerebral embolism, etc.), deep venous thrombosis and pulmonary embolism;
  • 16.The researcher judges digestive tract diseases or conditions that may affect drug absorption, including but not limited to active gastric and duodenal ulcers, ulcerative colitis or active bleeding of unresectable digestive tract tumors, or other conditions that may cause gastrointestinal bleeding or perforation as judged by the researcher, with various factors that affect oral drugs (such as inability to swallow, gastrointestinal resection, chronic diarrhea and intestinal obstruction, etc.);
  • 17.Individuals with hypertension who cannot be reduced to the normal range after antihypertensive drug treatment (systolic blood pressure ≥ 150mmHg or diastolic blood pressure ≥ 100mmHg)
  • 18.Surgery (except biopsy) was performed within 28 days before being enrolled in this study, or the surgical incision was not completely healed;
  • 19.Have received any other experimental drug treatment or participated in other intervention research within 4 weeks before signing the informed consent form;
  • 20.Pregnant (pregnancy test positive before medication) or breast-feeding women;
  • 21.According to the researcher's judgment, that is not suitable for patients in the group;

Trial locations and contacts

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

Ying Liu, MD contact

+86 137 8360 4602

yaya7207@126.com

China1 site, 1 recruiting

  • HeNan

    Zhengzhou

    Ying Liu, MD, +8613783604602, yaya7207@126.com

    Recruiting

Other trials in China

About this study

Official title: A Prospective, Single Arm Study of Adebrelimab Combined with Apatinib and Gemcitabine and Cisplatin (GP) First-line Treatment for Unresectable Biliary Tract Carcinoma

This study is designed to combine anti-angiogenic drugs on the basis of PD-L1+ gemcitabine/cisplatin, hoping to further improve the curative effect of advanced BTC treatment and provide more choices for first-line treatment of BTC in China.

Being tested
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

    adepelizumab ,1200mg, q3w

  • ApatinibDrug

    apatinib，250mg，QD

  • gemcitabine and cisplatinDrug

    cisplatin 25mg/m2，gemcitabine 1000mg/m2 d1,d8，q3w

Study groups in NCT06749730
Study groupRoleWhat they receive
adebrelimab combined with apatinib and gemcitabine and cisplatinExperimentalNot described
Receives: Drug: Adebrelimab; Drug: Apatinib; Drug: gemcitabine and cisplatin

What is being measured

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

  1. Progression-free Survival

    Progression-free Survival (PFS) is defined as the time from randomization to the first documented radiographic disease progression or death due to any cause, whichever occurs first, assessed by the Investigator per RECIST Version 1.1.

    Measured: From first dose of study intervention until disease progression or death (whichever occurs first), up to approximately 6 months after the last subject enrolled

Secondary outcomes (4)

  1. Overall Survival(OS)

    Overall Survival(OS) is defined as the time from the date of the first dose of study intervention until death due to any cause. The measures of interest are median Overall Survival(OS) and Overall Survival at 12 months(OS12).

    Measured: From first dose of study intervention until death, at least 12 months after the last subject enrolled

  2. Objective Response Rate (ORR)

    Objective Response Rate (ORR) is defined as the proportion of participants who achieved a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), assessed by BICR per RECIST Version 1.1.

    Measured: From first dose of study intervention until disease progression or death (whichever occurs first), up to approximately 3 months after the last subject enrolled

  3. Duration of Response(DOR)

    Duration of Response(DOR) is defined as the time from the date of first documented response until the date of documented progression per RECIST 1.1 as assessed by the investigator or death due to any cause.

    Measured: From first dose of study intervention until disease progression or death (whichever occurs first), up to approximately 6 months after the last subject enrolled

  4. Incidence of treatment-emergent adverse events(AEs)

    Incidence of treatment-emergent adverse events(AEs), including possible related adverse events(PRAEs), adverse event of special interests(AESIs), immune-mediated adverse events(imAEs), and serious adverse events(SAEs).

    Measured: From first dose of study intervention until 90 days after last dose or death (whichever occurs first)

Timeline

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

  1. First posted27 Dec 2024
  2. Study start1 Apr 2024
  3. Primary completionDec 2026 (estimated)
  4. Study completionJun 2027 (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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
63 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06749730
Sponsor's protocol ID
BTC-II-001
Status last verified
Jul 2024
First submitted
11 Jul 2024
Last updated
27 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Adebrelimab, Apatinib and gemcitabine and cisplatin in people with Unresectable Biliary Tract Carcinoma, run by Henan Cancer Hospital 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 9 inclusion and 21 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 27 Dec 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 Ying Liu, MD (+86 137 8360 4602, yaya7207@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival (time frame: From first dose of study intervention until disease progression or death (whichever occurs first), up to approximately 6 months after the last subject enrolled). 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 NCT06749730.

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 27 Dec 2024.

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