Biliary Tract CancerPhase 2NCT06465563

SHR-8068 in Combination With Adebrelimab, Bevacizumab, and Platinum-Based Chemotherapy as First-line Treatment in Patients With Advanced Biliary Tract Cancer

A Phase 2 study testing SHR-8068, Adebrelimab and Cisplatin in people with Biliary Tract Cancer, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 2 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Biliary Tract Cancer
What is being tested?: SHR-8068, Adebrelimab and Cisplatin
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 93 participants
Where: 2 sitesChina
Study dates: 1 Jul 2024to 30 Dec 2026
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

Age 18~75 years old, both male and female;
Histologically or cytologically confirmed unresectable locally advanced, or recurrent/metastatic biliary tract adenocarcinoma (including gallbladder cancer, intrahepatic cholangiocarcinoma, and extrahepatic cholangiocarcinoma);
Has not received prior systemic anti-tumor therapy;
At least one measurable lesion based on RECIST v1.1 criteria;
ECOG PS score: 0-1 points;
Expected survival period ≥ 3 months;

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Adequate organ function;
Must take one medically approved contraceptive measure;
Patients voluntarily joined the study and signed informed consent.

Who cannot join

history or concurrently has other solid tumor;
Patients with liver tumor burden greater than 50% of total liver volume;
History of previous hepatic encephalopathy;
Patients with biliary obstruction ， at risk of biliary tract infection;
Patients with undergone major surgical treatment within 4 weeks before randomization;
Patients with any active, known or suspected autoimmune disorder;

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Patients with active pulmonary tuberculosis;
Patients with known history of HIV or active hepatitis;
Untreated central nervous system metastasis;
Pleural or peritoneal effusion with clinical symptoms;
Patients with poorly controlled cardiac clinical symptoms or disease;
Patients with abnormal coagulation function and bleeding tendency;
Known allergic reaction to Adalimumab or other monoclonal antibodies, or to the trial drug;
Patients with other potential factors that may affect the study results.

Trial locations and contacts

2 sites in 1 country.

China2 sites

The First Affiliated Hospital，Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)
Nanjing, Jiangsu, 210029

Other trials in China

About this study

Official title: SHR-8068 in Combination With Adebrelimab, Bevacizumab, and Platinum-Based Chemotherapy for the First-Line Treatment of Advanced Biliary Tract Cancer: A Randomized and Exploratory Cohort, Open-label, Multicenter, Phase II Study

Cohort A and B: This cohort aims to evaluate the efficacy and safety of SHR-8068 and Adebrelimab in combination with Cisplatin plus Gemcitabine (CisGem), compared with Adebrelimab in combination with CisGem, as first-line treatment in patients with Advanced Biliary Tract cancer. Cohort C: This cohort aims to evaluate the efficacy and safety of SHR-8068 and Adebrelimab and Bevacizumab in combination with Cisplatin Plus Gemcitabine (CisGem) as first-line treatment in patients with Advanced Biliary Tract cancer.

Conditions: Biliary Tract Cancer
Being tested: SHR-8068, Adebrelimab, Cisplatin, Gemcitabine, Bevacizumab Injection
Medical subject headings: Biliary Tract Neoplasms

What participants receive

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

SHR-8068Drug
SHR-8068
AdebrelimabDrug
Adebrelimab
CisplatinDrug
Cisplatin
GemcitabineDrug
Gemcitabine
Bevacizumab InjectionDrug
Bevacizumab injection.

Study groups in NCT06465563
Study group	Role	What they receive
Arm A: SHR-8068, Adebrelimab, Cisplatin and Gemcitabine	Experimental	Not described Receives: Drug: SHR-8068; Drug: Adebrelimab; Drug: Cisplatin; Drug: Gemcitabine
Arm B: Adebrelimab, Cisplatin and Gemcitabine	Experimental	Not described Receives: Drug: Adebrelimab; Drug: Cisplatin; Drug: Gemcitabine
Arm C: SHR-8068, Adebrelimab, Bevacizumab, Cisplatin and Gemcitabine	Experimental	Not described Receives: Drug: SHR-8068; Drug: Adebrelimab; Drug: Cisplatin; Drug: Gemcitabine; Drug: Bevacizumab Injection

What is being measured

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

Objective Response Rate (ORR)
ORR is defined as the proportion of participants with Complete Response (CR) or Partial Response (PR), as determined by the investigator according to RECIST v1.1.
Measured: From Randomization to the first occurrence of disease progression or initiation of new anti-tumor therapy (up to approximately 14 months)

Secondary outcomes (3)

Disease Control Rate (DCR)
DCR is defined as the proportion of participants with Complete Response (CR), Partial Response (PR) or Stable Disease (SD), as determined by the investigator according to RECIST v1.1.
Measured: From Randomization to the first occurrence of disease progression or initiation of new anti-tumor therapy (up to approximately 14 months)] (up to approximately 14 months)
Progression-Free-Survival (PFS)
PFS is defined as the time from randomization to the first occurrence of disease progression as determined by the investigator according to RECIST v1.1 or death from any cause (whichever occurs first).
Measured: From randomization to the first occurrence of disease progression as determined by the investigator according to RECIST v1.1 or death from any cause (whichever occurs first) (up to approximately 14 months)
Duration of Response (DoR)
DoR is defined as the time from the first occurrence of a confirmed objective response to disease progression as determined by the investigator according to RECIST v1.1 or death from any cause (whichever occurs first).
Measured: From the first occurrence of a confirmed objective response to disease progression as determined by the investigator according to RECIST v1.1 or death from any cause (whichever occurs first) (up to approximately 14 months)

Timeline

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

1 Jul 202430 Dec 2026

First posted20 Jun 2024
Study start1 Jul 2024
Primary completion30 Dec 2026 (estimated)
Study completion30 Dec 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Biliary Tract CancerStudies of the same condition, open and under way.
More trials run by Suzhou Suncadia Biopharmaceuticals Co., Ltd.The 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: Randomised
Intervention model: Parallel groups
Model description: This study is a randomized and exploratory cohort, open-label, multicenter, Phase II clinical trial aimed at evaluating the efficacy and safety of SHR-8068 in combination with Adebrelimab, Bevacizumab, and Platinum-based chemotherapy as first-line treatment for advanced biliary tract cancer. The primary endpoint of the study is the Objective Response Rate (ORR), assessed by investigators based on RECIST v1.1 criteria.
Masking: None (open label)
Enrolment: 93 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06465563
Sponsor's protocol ID: SHR-8068-201-BTC
Status last verified: May 2026
First submitted: 13 Jun 2024
Last updated: 29 May 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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
RecruitingObservational study
Tissue Procurement and Natural History Study of Patients With Malignant Mesothelioma
Thymoma, Stomach Neoplasms
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

All Biliary Tract Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: SHR-8068 in Combination With Adebrelimab, Bevacizumab, and Platinum-Based Chemotherapy for the First-Line Treatment of Advanced Biliary Tract Cancer: A Randomized and Exploratory Cohort, Open-label, Multicenter, Phase II Study
ClinicalTrials.gov ID: NCT06465563
Acronym / sponsor ID: SHR-8068-201-BTC
Conditions: Biliary Tract Cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 93 participants (actual)
Lead sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
Study start: 1 Jul 2024 (actual)
Primary completion: 30 Dec 2026 (estimated)
Study completion: 30 Dec 2026 (estimated)
First posted: 20 Jun 2024 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3
Model description: This study is a randomized and exploratory cohort, open-label, multicenter, Phase II clinical trial aimed at evaluating the efficacy and safety of SHR-8068 in combination with Adebrelimab, Bevacizumab, and Platinum-based chemotherapy as first-line treatment for advanced biliary tract cancer. The primary endpoint of the study is the Objective Response Rate (ORR), assessed by investigators based on RECIST v1.1 criteria.

Arm	Type	Receives
Arm A: SHR-8068, Adebrelimab, Cisplatin and Gemcitabine	Experimental	Drug: SHR-8068, Drug: Adebrelimab, Drug: Cisplatin, Drug: Gemcitabine
Arm B: Adebrelimab, Cisplatin and Gemcitabine	Experimental	Drug: Adebrelimab, Drug: Cisplatin, Drug: Gemcitabine
Arm C: SHR-8068, Adebrelimab, Bevacizumab, Cisplatin and Gemcitabine	Experimental	Drug: SHR-8068, Drug: Adebrelimab, Drug: Cisplatin, Drug: Gemcitabine, Drug: Bevacizumab Injection

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Age 18~75 years old, both male and female;
Histologically or cytologically confirmed unresectable locally advanced, or recurrent/metastatic biliary tract adenocarcinoma (including gallbladder cancer, intrahepatic cholangiocarcinoma, and extrahepatic cholangiocarcinoma);
Has not received prior systemic anti-tumor therapy;
At least one measurable lesion based on RECIST v1.1 criteria;
ECOG PS score: 0-1 points;

Key exclusion criteria (14 listed)

history or concurrently has other solid tumor;
Patients with liver tumor burden greater than 50% of total liver volume;
History of previous hepatic encephalopathy;
Patients with biliary obstruction ， at risk of biliary tract infection;
Patients with undergone major surgical treatment within 4 weeks before randomization;

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
SHR-8068SHR-8068	Drug	Arm A: SHR-8068, Adebrelimab, Cisplatin and Gemcitabine, Arm C: SHR-8068, Adebrelimab, Bevacizumab, Cisplatin and Gemcitabine
AdebrelimabAdebrelimab	Drug	Arm A: SHR-8068, Adebrelimab, Cisplatin and Gemcitabine, Arm B: Adebrelimab, Cisplatin and Gemcitabine, Arm C: SHR-8068, Adebrelimab, Bevacizumab, Cisplatin and Gemcitabine
CisplatinCisplatin	Drug	Arm A: SHR-8068, Adebrelimab, Cisplatin and Gemcitabine, Arm B: Adebrelimab, Cisplatin and Gemcitabine, Arm C: SHR-8068, Adebrelimab, Bevacizumab, Cisplatin and Gemcitabine
GemcitabineGemcitabine	Drug	Arm A: SHR-8068, Adebrelimab, Cisplatin and Gemcitabine, Arm B: Adebrelimab, Cisplatin and Gemcitabine, Arm C: SHR-8068, Adebrelimab, Bevacizumab, Cisplatin and Gemcitabine
Bevacizumab InjectionBevacizumab injection.	Drug	Arm C: SHR-8068, Adebrelimab, Bevacizumab, Cisplatin and Gemcitabine

Primary outcome

Objective Response Rate (ORR)
Time frame: From Randomization to the first occurrence of disease progression or initiation of new anti-tumor therapy (up to approximately 14 months)
ORR is defined as the proportion of participants with Complete Response (CR) or Partial Response (PR), as determined by the investigator according to RECIST v1.1.

3 secondary outcomes

Disease Control Rate (DCR)
Time frame: From Randomization to the first occurrence of disease progression or initiation of new anti-tumor therapy (up to approximately 14 months)] (up to approximately 14 months)
Progression-Free-Survival (PFS)
Time frame: From randomization to the first occurrence of disease progression as determined by the investigator according to RECIST v1.1 or death from any cause (whichever occurs first) (up to approximately 14 months)
Duration of Response (DoR)
Time frame: From the first occurrence of a confirmed objective response to disease progression as determined by the investigator according to RECIST v1.1 or death from any cause (whichever occurs first) (up to approximately 14 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 29 May 2026.
Individual participant dataSharing planned: Undecided

Related trials for Biliary Tract Cancer

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
RecruitingObservational study
Tissue Procurement and Natural History Study of Patients With Malignant Mesothelioma
Thymoma, Stomach Neoplasms
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

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. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SHR-8068, Adebrelimab and Cisplatin in people with Biliary Tract Cancer, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 2 sites 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 14 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: under way, not looking for participants, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: From Randomization to the first occurrence of disease progression or initiation of new anti-tumor therapy (up to approximately 14 months)). 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 NCT06465563.

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 29 May 2026.