Biliary Tract CarcinomaPhase 2HP-BTC-002NCT07062328
A Trial of Recaticimab and Adebrelimab in Combination With Chemotherapy in Patients With Unresectable BTC
A Phase 2 study testing Recaticimab and Adebrelimab and GP chemotherapy in people with Biliary Tract Carcinoma, run by Sun Yat-sen University.
Trial summary
The study aims to evaluate the efficacy and safety of Recaticimab and Adebrelimab in Combination With chemotherapy in patients with metastatic biliary tract carcinoma (BTC). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Biliary Tract Carcinoma
- What is being tested?
- Recaticimab and Adebrelimab and GP chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- No sites listed yet
- Study dates
- 10 Jul 2025to 20 Apr 2028
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Provided informed consent and sign the informed consent form;
- 2. Male or female, Aged 18-75 years (counted on the date of signing informed consent);
- 3. Histologically confirmed unresectable advanced or metastatic biliary tract adenocarcinoma, including cholangiocarcinoma (intrahepatic or extrahepatic) and gallbladder carcinoma.;
- 4. The patient is not a candidate for surgery, or the disease has progressed after prior surgery and/or local treatment.
- 5. No previous systematic treatment for advanced BTC. Exceptions include patients who relapsed more than 6 months after adjuvant chemotherapy following radical resection. Local regional therapy (including but not limited to surgery, radiotherapy, hepatic artery embolization, TACE, hepatic arterial infusion, radiofrequency ablation, cryoablation or percutaneous ethanol injection) must have been completed at least 4 weeks prior to baseline radiological scanning, and any toxicity (except alopecia) induced by local regional therapy must have resolved to ≤ Grade 1 in accordance with National Cancer Institute - Common Terminology Criteria for Adverse Event version 5.0 (NCI-CTCAE v5.0);
- 6. No prior treatment with immune-mediated therapy, including but not limited to other anti-CTLA-4, anti-PD-1, anti-PD-L1, and anti-PD-L2 antibodies, with the exception of therapeutic anticancer vaccines and adjuvant immunotherapy administered after curative resection
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- 7. Have at least one measurable lesion (in accordance with RECIST v1.1, major diameter ≥ 10 mm of the measurable lesion in spiral CT scan or short diameter of swollen lymph node ≥ 15 mm; the lesion with previous local therapy can be used as target lesion after the progression is confirmed in accordance with RECIST v1.1)
- 8. Child-Pugh class: Grade A
- 9. ECOG-PS score: 0-1;
- 10. With a life expectancy of ≥ 12 weeks;
- 11. Adequate major organ function without severe hematologic, cardiac, pulmonary, hepatic, renal, or bone marrow dysfunction, and no immunodeficiency disease;
- 12. For active hepatitis B, it is required that effective antiviral treatment be received (according to local standard therapy, such as entecavir or tenofovir), with HBV DNA ≤ 2000 IU/mL or a reduction of HBV DNA by 10 times after antiviral treatment, and the patient must agree to continue effective anti-HBV treatment throughout the study period;
- 13. Women of childbearing potential must agree to abstain from heterosexual intercourse or use reliable contraception from the time of signing informed consent until at least 120 days after the last study drug administration. A negative serum pregnancy test (HCG) must be confirmed within 7 days before starting study treatment. Lactating women are excluded;
- 14. Men with female partners of childbearing potential must agree to abstain from heterosexual intercourse or use reliable contraception from the time of signing informed consent until at least 120 days after the last study drug administration. Men must also agree not to donate sperm during this period. For men whose partners are pregnant, condom use is required without additional contraception;
Who cannot join
- 1. Other active malignant tumor exceptBTCwithin 5 years or simultaneously. Cured localized tumor, for example, basal cell carcinoma of skin, squamous cell carcinoma of skin, superficial bladder cancer, carcinoma in situ of prostate, carcinoma in situs of cervix, breast cancer in situ may be enrolled;
- 2. A previous diagnosis of nephrotic syndrome, severe liver disease, Cushing's syndrome, or other diseases that significantly affect lipid levels; a history of low cholesterol, low lipidemia, or related family history, or a family history of allergy to PCSK inhibitors
- 3. Planning to or previously received organ or allogenic bone marrow transplantation;
- 4. Treatment of other investigational product(s) within 28 days prior to the start of study treatment;
- 5. Moderate or severe ascites with clinical symptoms that require therapeutic puncture and drainage, or Child-Pugh score >2 (excluding those with only a small amount of ascites on imaging without accompanying clinical symptoms); uncontrolled or moderate to large pleural effusion, pericardial effusion;
- 6. History of gastrointestinal bleeding within 6 months prior to the start of study treatment or clear tendency of gastrointestinal bleeding;For example, those with a risk of bleeding or severe esophageal and gastric varices, active local gastrointestinal ulcer lesions, persistent positive fecal occult blood test cannot be enrolled (if the fecal occult blood test is positive at baseline, it can be rechecked. If it remains positive after re-examination, an endoscopy (EGD) should be performed. Those who are found to have esophageal and gastric varices with a high risk of bleeding by EGD cannot be enrolled);
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- 7. Abdominal fistula, gastrointestinal perforation or intraperitoneal abscess within 6 months prior to the start of study treatment
- 8. Known genetic or acquired hemorrhage (e.g., coagulation dysfunction) or thrombotic tendency, for example, subject with hemophilia; current or recent (within 10 days prior to the start of study treatment) use of full-dose of oral or intravenous anticoagulant or thrombolytic drug for the purpose of treatment (preventive use of low-dose aspirin or low molecular weight heparin is allowed);
- 9. Current or recent (within 10 days prior to the start of study treatment) use of aspirin (> 325 mg/day, maximum dose for antiplatelet) or dipyridamole, ticlopidine, clopidogrel and cilostazol;
- 10. Thrombosis or thromboembolic event within 6 months prior to the start of study treatment, for example, cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), pulmonary embolism;
- 11. Cardiac clinical symptom or disease that is not well controlled;
- 12. Hypertension that cannot be well controlled through antihypertensive drugs, allowing to reach the above parameters by the use of antihypertensive therapy; previous hypertensive crisis or hypertensive encephalopathy;
- 13. Major vascular disease within 6 months prior to the start of study treatment (for example, aortic aneurysm requiring surgical repair or peripheral arterial thrombosis in recent days); Serious, unhealed or splitting wound and active ulcer or untreated bone fracture; Major surgical therapy within 4 weeks prior to the start of study treatment (except diagnosis), or planned major surgery during the study;
- 14. Evidence on intraperitoneal pneumatosis that can not be explained by puncture or recent surgery;
- 15. Previous or current presence of metastasis to central nervous system; Metastatic disease involving main airway or blood vessels (e.g. Vena cava tumor invasion or complete occlusion of the major portal vein due to HCC, the major portal vein is defined as the part of portal vein between the union of the splenic and superior mesenteric veins and the first bifurcation into the left and right vein) or high-volume mediastinal tumor mass located in the center (distance from carina <30 mm);
- 16. History of hepatic encephalopathy; Current interstitial pneumonia or interstitial lung disease, or history of interstitial pneumonia or interstitial lung disease which required hormonal therapy, or other pulmonary fibrosis that may interfere with the judgement and treatment of immune-related pulmonary toxicity; organizing pneumonia (e.g., obliterative bronchiolitis), pneumoconiosis, drug related pneumonitis, idiopathic pneumonia, subjects with evidence on active pneumonia or serious pulmonary function impairment on thoracic computed tomography (CT) in screening period (previous radiation pneumonitis in the radiation area will be allowed); active tuberculosis;
- 17. Active autoimmune disease or history of autoimmune disease and may relapse (including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism [with the exception that it can be controlled by hormone replacement therapy]). Subjects with skin disease that do not require systemic treatment are eligible, for example, leukoderma, psoriasis, alopecia; subjects with controlled type 1 diabetes by insulin are eligible; subjects with asthma that has been completely resolved in childhood and don't need any treatment are eligible, but subjects with asthma that require a bronchodilator as medical intervention are not eligible;
- 18. Use of immunosuppressive medication within 14 days prior to the start of study treatment, or systemic corticosteroid therapy to achieve the objective of immunosuppression (Prednisone at the dose of >10mg/day or equivalent);
- 19. Known history of hypersensitivity to the active substance or to any other components of each investigational medicinal product;
- 20. Severe infection within 4 weeks prior to the start of study treatment, including but not limited to hospitalization for infection, bacteremia or complications of severe pneumonia; oral or intravenous therapeutic antibiotics within 2 weeks prior to the start of study treatment (subjects who are treated with antibiotics for prevention, e.g., preventive urinary tract infection or exacerbation of chronic obstructive pulmonary disease are eligible for participation in the study);
- 21. Congenital or acquired immunodeficiency (e.g., HIV infection);
- 22. Hepatitis B and hepatitis C co-infection;
- 23. Attenuated live vaccine therapy administered within 28 days prior to the start of study treatment, or are expected to receive such vaccines during Adebrelimab treatment or within 60 days after the last dose of Adebrelimab;
- 24. Other factors that may affect the study results or lead to early study termination as judged by investigators, such as alcoholism, drug abuse, other serious diseases (including mental disorders) requiring concomitant therapy, with serious laboratory examination abnormality, with family or social factors, that may affect subject's safety.
- 25.Other conditions in which the investigator deems the subject unsuitable for participation in the clinical trial.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Efficacy and Safety of Recaticimab (PCSK9 Inhibitor) and Adebrelimab Combined With Chemotherapy as First-line Treatment for Unresectable/ Advanced Biliary Tract Carcinoma: A Single-arm, Phase II Study
The study aims to evaluate the efficacy and safety of Recaticimab and Adebrelimab in Combination With chemotherapy in patients with metastatic biliary tract carcinoma (BTC).
Read the detailed description
The investigators are conducting a clinical research study to evaluate the effectiveness and safety of a novel combination therapy for patients with advanced, unresectable biliary tract carcinoma
- Conditions
- Biliary Tract Carcinoma
- Being tested
- Recaticimab and Adebrelimab, GP chemotherapy
- Keywords
- GP chemotherapy, Antineoplastic Agents, PCSK9 Inhibitor, Immune Checkpoint Inhibitors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recaticimab and AdebrelimabDrug
Patients would receive Recaticimab (150 mg, sc., q4w) and Adebrelimab (1200 mg, iv., q3w) plus GP chemotherapy in 21day cycles.
Recaticimab and Adebrelimab would be maintained until the disease progressed or intolerable toxicity and adverse reactions or the medication was used for two years.
GP chemotherapyDrug
Gemcitabine/Cisplatin (gemcitabine 1000mg/m2 + cisplatin 25mg/m2) will be administered on D1/D8 in every three weeks cycle, up to 6 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Recaticimab and Adebrelimab in Combination With chemotherapy | Experimental | Adebrelimab (SHR-1316) is a novel humanised IgG4 monoclonal antibody against PD-L1.
Recaticimab is a new humanized IgG1 monoclonal antibody developed to selectively target PCSK9 with the potential for durable action. Receives: Drug: Recaticimab and Adebrelimab; Drug: GP chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
objective response rate (ORR)
Defined as percentage of participants achieving assessed complete response (CR) and partial response (PR) by the investigator according to the RECIST 1.1.
Measured: up to 24 months
Secondary outcomes (3)
Disease Control Rate (DCR)
DCR was defined as the percentage of participants who have a confirmed complete response（CR） or partial response（PR） or stable disease（SD） per RECIST 1.1 as assessed by investigator
Measured: up to 24 months
Progression-Free Survival (PFS)
PFS is defined as the time from enrollment to the first documented disease progression or death due to any cause, whichever occurs first. Responses are according to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by investigator
Measured: up to 24 months
Adverse Events (AE)
Overall incidence of adverse events (AE); incidence of grade 3 or higher AE; incidence of severe adverse events (SAE); incidence of AEs leading to discontinuation of drug use; incidence of AEs leading to suspension of drug use.
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2025
- Study start10 Jul 2025 (estimated)
- Primary completion10 Dec 2026 (estimated)
- Study completion20 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary Tract CarcinomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Model description
- Recaticimab and Adebrelimab in Combination With chemotherapy
- Masking
- None (open label)
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu Hengrui Pharmaceutical Co., Ltd.
- Responsible party
- Principal investigator, Dong sheng Zhang, Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07062328
- Sponsor's protocol ID
- SL-B2025-251-02
- Acronym
- HP-BTC-002
- Status last verified
- Jul 2025
- First submitted
- 2 Jul 2025
- Last updated
- 14 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Recaticimab (PCSK9 Inhibitor) and Adebrelimab Combined With Chemotherapy as First-line Treatment for Unresectable/ Advanced Biliary Tract Carcinoma: A Single-arm, Phase II Study
- ClinicalTrials.gov ID
- NCT07062328
- Acronym / sponsor ID
- HP-BTC-002 / SL-B2025-251-02
- Conditions
- Biliary Tract Carcinoma
- Keywords
- GP chemotherapy, Antineoplastic Agents, PCSK9 Inhibitor, Immune Checkpoint Inhibitors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Jiangsu Hengrui Pharmaceutical Co., Ltd.
- Study start
- 10 Jul 2025 (estimated)
- Primary completion
- 10 Dec 2026 (estimated)
- Study completion
- 20 Apr 2028 (estimated)
- First posted
- 14 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to evaluate the efficacy and safety of Recaticimab and Adebrelimab in Combination With chemotherapy in patients with metastatic biliary tract carcinoma (BTC).
Detailed description
The investigators are conducting a clinical research study to evaluate the effectiveness and safety of a novel combination therapy for patients with advanced, unresectable biliary tract carcinoma
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Recaticimab and Adebrelimab in Combination With chemotherapy
| Arm | Type | Receives |
|---|---|---|
| Recaticimab and Adebrelimab in Combination With chemotherapy | Experimental | Drug: Recaticimab and Adebrelimab, Drug: GP chemotherapyAdebrelimab (SHR-1316) is a novel humanised IgG4 monoclonal antibody against PD-L1. Recaticimab is a new humanized IgG1 monoclonal antibody developed to selectively target PCSK9 with the potential for durable action. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 1. Provided informed consent and sign the informed consent form;
- 2. Male or female, Aged 18-75 years (counted on the date of signing informed consent);
- 3. Histologically confirmed unresectable advanced or metastatic biliary tract adenocarcinoma, including cholangiocarcinoma (intrahepatic or extrahepatic) and gallbladder carcinoma.;
- 4. The patient is not a candidate for surgery, or the disease has progressed after prior surgery and/or local treatment.
- 5. No previous systematic treatment for advanced BTC. Exceptions include patients who relapsed more than 6 months after adjuvant chemotherapy following radical resection. Local regional therapy (including but not limited to surgery, radiotherapy, hepatic artery embolization, TACE, hepatic arterial infusion, radiofrequency ablation, cryoablation or percutaneous ethanol injection) must have been completed at least 4 weeks prior to baseline radiological scanning, and any toxicity (except alopecia) induced by local regional therapy must have resolved to ≤ Grade 1 in accordance with National Cancer Institute - Common Terminology Criteria for Adverse Event version 5.0 (NCI-CTCAE v5.0);
Key exclusion criteria (25 listed)
- 1. Other active malignant tumor exceptBTCwithin 5 years or simultaneously. Cured localized tumor, for example, basal cell carcinoma of skin, squamous cell carcinoma of skin, superficial bladder cancer, carcinoma in situ of prostate, carcinoma in situs of cervix, breast cancer in situ may be enrolled;
- 2. A previous diagnosis of nephrotic syndrome, severe liver disease, Cushing's syndrome, or other diseases that significantly affect lipid levels; a history of low cholesterol, low lipidemia, or related family history, or a family history of allergy to PCSK inhibitors
- 3. Planning to or previously received organ or allogenic bone marrow transplantation;
- 4. Treatment of other investigational product(s) within 28 days prior to the start of study treatment;
- 5. Moderate or severe ascites with clinical symptoms that require therapeutic puncture and drainage, or Child-Pugh score >2 (excluding those with only a small amount of ascites on imaging without accompanying clinical symptoms); uncontrolled or moderate to large pleural effusion, pericardial effusion;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recaticimab and AdebrelimabPatients would receive Recaticimab (150 mg, sc., q4w) and Adebrelimab (1200 mg, iv., q3w) plus GP chemotherapy in 21day cycles. Recaticimab and Adebrelimab would be maintained until the disease progressed or intolerable toxicity and adverse reactions or the medication was used for two years. | Drug | Recaticimab and Adebrelimab in Combination With chemotherapy |
| GP chemotherapyGemcitabine/Cisplatin (gemcitabine 1000mg/m2 + cisplatin 25mg/m2) will be administered on D1/D8 in every three weeks cycle, up to 6 cycles. | Drug | Recaticimab and Adebrelimab in Combination With chemotherapy |
Primary outcome
objective response rate (ORR)
Time frame: up to 24 months
Defined as percentage of participants achieving assessed complete response (CR) and partial response (PR) by the investigator according to the RECIST 1.1.
3 secondary outcomes
Disease Control Rate (DCR)
Time frame: up to 24 months
Progression-Free Survival (PFS)
Time frame: up to 24 months
Adverse Events (AE)
Time frame: up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
- Individual participant dataSharing planned: No
Related trials for Biliary Tract Carcinoma
Active, not recruitingPhase 2/3
A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002)
Biliary Tract Cancer, Cholangiocarcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Active, not recruitingPhase 2
Durvalumab and Tremelimumab in Combination With Propranolol and Chemotherapy for Treatment of Advanced Hepatopancreabiliary Tumors (BLOCKED)
Pancreatic Cancer, Hepatocellular Cancer
Not yet recruitingPhase 3
Hepatic Arterial Infusion Chemotherapy Versus Capecitabine as Adjuvant Therapy for Resected Biliary Tract Cancer
Biliary Tract Cancer, Cholangiocarcinoma
RecruitingPhase 2
MP0317 in Combination With Chemoimmunotherapy in First Line Treatment for Patients With Advanced Biliary Tract Carcinoma
Advanced Biliary Tract Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Recaticimab and Adebrelimab and GP chemotherapy in people with Biliary Tract Carcinoma, run by Sun Yat-sen University.
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 14 inclusion and 25 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: opening soon, as of the sponsor's last update on 14 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Dongsheng Zhang (020-87343795, zhangdsh@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
objective response rate (ORR) (time frame: up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jul 2025.