Advanced Biliary Tract CancerPhase 3NCT07229625
A Phase III Study of SHR-8068 in Combination With Adebrelimab and Platinum-Containing Chemotherapy Versus Durvalumab in Combination With Platinum-Containing Chemotherapy as First-line Treatment for Advanced Biliary Tract Cancer (BTC)
A Phase 3 study testing SHR-8068 Injection, Adebrelimab Injection and Gemcitabine Hydrochloride for Injection in people with Advanced Biliary Tract Cancer, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 1 site in China.
Trial summary
This study is a randomized, open-label, multicenter phase III clinical trial, aiming to evaluate the efficacy and safety of SHR-8068 combined with adbelimab and platinum-based chemotherapy in contrast to varicumab combined with platinum-based chemotherapy in the first-line treatment of patients with advanced BTC. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Biliary Tract Cancer
- What is being tested?
- SHR-8068 Injection, Adebrelimab Injection and Gemcitabine Hydrochloride for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 604 participants
- Where
- 1 siteChina
- Study dates
- 21 Jan 2026to Dec 2029
- Phase
- Phase 3
- 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
- Locally advanced or recurrent/metastatic biliary adenocarcinoma that is inoperable and confirmed by histology or cytology;
- No previous systemic anti-tumor treatment has been received;
- At least one measurable lesion that complies with the RECIST v1.1 standard;
- ECOG PS score: 0-1 point;
- The expected survival period is ≥ 3 months;
- Good organ function level;
- Negative blood pregnancy (for women of childbearing age) and not in the lactation period, adhering to efficient contraceptive requirements;
- Patients voluntarily joined this study and signed informed consent.
Who cannot join
- Other pathological types of cholangiocarcinoma other than adenocarcinoma;
- Malignant tumor of the ampulla;
- Have had or concurrently suffered from other malignant tumors;
- Those with concurrent biliary obstruction and at risk of biliary tract infection;
- Those with any active or known autoimmune diseases.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310003
Yanbo Liang, +86-0571-87236688, liangtingbo@zju.edu.cn
Xueli Bai, +86-0571-87236857, shirleybai@zju.edu.cn
About this study
Official title: A Phase III, Randomized, Controlled, Open-Label, Multicenter Study of SHR-8068 in Combination With Adebrelimab and Platinum-Containing Chemotherapy Versus Durvalumab in Combination With Platinum-Containing Chemotherapy as First-Line Treatment for Advanced Biliary Tract Cancer (BTC)
This study is a randomized, open-label, multicenter phase III clinical trial, aiming to evaluate the efficacy and safety of SHR-8068 combined with adbelimab and platinum-based chemotherapy in contrast to varicumab combined with platinum-based chemotherapy in the first-line treatment of patients with advanced BTC.
- Conditions
- Advanced Biliary Tract Cancer
- Being tested
- SHR-8068 Injection, Adebrelimab Injection, Gemcitabine Hydrochloride for Injection, Cisplatin Injection, Durvalumab Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-8068 InjectionDrug
SHR-8068 injection.
Adebrelimab InjectionDrug
Adebrelimab injection.
Gemcitabine Hydrochloride for InjectionDrug
Gemcitabine Hydrochloride for injection.
Cisplatin InjectionDrug
Cisplatin injection.
Durvalumab InjectionDrug
Durvalumab injection.
| Study group | Role | What they receive |
|---|---|---|
| SHR-8068 + Adebrelimab + Cisplatin and Gemcitabine Group | Experimental | Not described Receives: Drug: SHR-8068 Injection; Drug: Adebrelimab Injection; Drug: Gemcitabine Hydrochloride for Injection; Drug: Cisplatin Injection |
| Durvalumab + Cisplatin and Gemcitabine Group | Active comparator | Not described Receives: Drug: Gemcitabine Hydrochloride for Injection; Drug: Cisplatin Injection; Drug: Durvalumab Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
Measured: Up to 15 months.
Secondary outcomes (8)
Disease Control Rate (DCR)
Measured: Up to 7 months.
Duration of Response (DoR)
Measured: Up to 7 months.
Progression free Survival (PFS)
Measured: Up to 7 months.
Objective Response Rate (ORR)
Measured: Up to 7 months.
Time to Progression (TTP)
Measured: Up to 7 months.
Time to Response (TTR)
Measured: Up to 7 months.
Adverse events (AEs)
Measured: Up to approximately 15 months.
Serious adverse events (SAEs)
Measured: Up to approximately 15 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study start21 Jan 2026
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 604 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07229625
- Sponsor's protocol ID
- SHR-8068-303
- Status last verified
- Jan 2026
- First submitted
- 13 Nov 2025
- Last updated
- 28 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized, Controlled, Open-Label, Multicenter Study of SHR-8068 in Combination With Adebrelimab and Platinum-Containing Chemotherapy Versus Durvalumab in Combination With Platinum-Containing Chemotherapy as First-Line Treatment for Advanced Biliary Tract Cancer (BTC)
- ClinicalTrials.gov ID
- NCT07229625
- Acronym / sponsor ID
- SHR-8068-303
- Conditions
- Advanced Biliary Tract Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 604 participants (estimated)
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 21 Jan 2026 (actual)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 17 Nov 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.
This study is a randomized, open-label, multicenter phase III clinical trial, aiming to evaluate the efficacy and safety of SHR-8068 combined with adbelimab and platinum-based chemotherapy in contrast to varicumab combined with platinum-based chemotherapy in the first-line treatment of patients with advanced BTC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SHR-8068 + Adebrelimab + Cisplatin and Gemcitabine Group | Experimental | Drug: SHR-8068 Injection, Drug: Adebrelimab Injection, Drug: Gemcitabine Hydrochloride for Injection, Drug: Cisplatin Injection |
| Durvalumab + Cisplatin and Gemcitabine Group | Active comparator | Drug: Gemcitabine Hydrochloride for Injection, Drug: Cisplatin Injection, Drug: Durvalumab Injection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Locally advanced or recurrent/metastatic biliary adenocarcinoma that is inoperable and confirmed by histology or cytology;
- No previous systemic anti-tumor treatment has been received;
- At least one measurable lesion that complies with the RECIST v1.1 standard;
- ECOG PS score: 0-1 point;
- The expected survival period is ≥ 3 months;
Key exclusion criteria (5 listed)
- Other pathological types of cholangiocarcinoma other than adenocarcinoma;
- Malignant tumor of the ampulla;
- Have had or concurrently suffered from other malignant tumors;
- Those with concurrent biliary obstruction and at risk of biliary tract infection;
- Those with any active or known autoimmune diseases.
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-8068 InjectionSHR-8068 injection. | Drug | SHR-8068 + Adebrelimab + Cisplatin and Gemcitabine Group |
| Adebrelimab InjectionAdebrelimab injection. | Drug | SHR-8068 + Adebrelimab + Cisplatin and Gemcitabine Group |
| Gemcitabine Hydrochloride for InjectionGemcitabine Hydrochloride for injection. | Drug | Durvalumab + Cisplatin and Gemcitabine Group, SHR-8068 + Adebrelimab + Cisplatin and Gemcitabine Group |
| Cisplatin InjectionCisplatin injection. | Drug | Durvalumab + Cisplatin and Gemcitabine Group, SHR-8068 + Adebrelimab + Cisplatin and Gemcitabine Group |
| Durvalumab InjectionDurvalumab injection. | Drug | Durvalumab + Cisplatin and Gemcitabine Group |
Primary outcome
Overall Survival (OS)
Time frame: Up to 15 months.
8 secondary outcomes
Disease Control Rate (DCR)
Time frame: Up to 7 months.
Duration of Response (DoR)
Time frame: Up to 7 months.
Progression free Survival (PFS)
Time frame: Up to 7 months.
Objective Response Rate (ORR)
Time frame: Up to 7 months.
Time to Progression (TTP)
Time frame: Up to 7 months.
Time to Response (TTR)
Time frame: Up to 7 months.
Adverse events (AEs)
Time frame: Up to approximately 15 months.
Serious adverse events (SAEs)
Time frame: Up to approximately 15 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 28 Jan 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SHR-8068 Injection, Adebrelimab Injection and Gemcitabine Hydrochloride for Injection in people with Advanced Biliary Tract Cancer, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. 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 8 inclusion and 5 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 28 Jan 2026. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Xin Shi (+86-0518-82342973, xin.shi.xs3@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (OS) (time frame: Up to 15 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 28 Jan 2026.