Resectable Intrahepatic Cholangiocarcinoma With High Risk of RecurrencePhase 2NCT06280508
Chemotherapy Combined With Adebrelimab and Apatinib as the Perioperative Treatment in Patients With Biliary Tract Cancer
A Phase 2 study testing Adebrelimab, Apatinib, Gemcitabine, cisplatin in people with Resectable Intrahepatic Cholangiocarcinoma With High Risk of Recurrence, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial summary
This is a prospective, single-arm exploratory study to evaluate the efficacy and safety of chemotherapy combined with Adebrelimab and Apatinib as the perioperative treatment in Patients With Biliary Tract Cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Resectable Intrahepatic Cholangiocarcinoma With High Risk of Recurrence
- What is being tested?
- Adebrelimab, Apatinib, Gemcitabine, cisplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2024to 31 Mar 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- confirmed intrahepatic cholangiocarcinoma
- with Resectable tumor lesion
- no contraindications to surgery
- with high risk of tumour recurrence
- No prior systemic therapy for intrahepatic cholangiocarcinoma.
- ECOG Performance Status of 0 or 1
- Child-Pugh Class: Grade A
Who cannot join
- History of gastrointestinal hemorrhage within 6 months prior to the start of study treatment or clear tendency of gastrointestinal hemorrhage
- Abdominal fistula, gastrointestinal perforation or intraperitoneal abscess within 6 months prior to the start of study treatment
- Known genetic or acquired hemorrhage or thrombotic tendency
- Thrombosis or thromboembolic event within 6 months prior to the start of study treatment
- Cardiac clinical symptom or disease that is not well controlled
- Hypertension that can not be well controlled through antihypertensive drugs
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
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guangzhou, China/Guangdong
Yajin Chen, 13719006202, cyj0509@126.com
Changzhen Shang, 13711279678, shangchangzhen@139.com
About this study
Official title: A Prospective, Single-arm Exploratory Trail of Chemotherapy Combined With Adebrelimab and Apatinib as the Perioperative Treatment in Patients With Biliary Tract Cancer
This is a prospective, single-arm exploratory study to evaluate the efficacy and safety of chemotherapy combined with Adebrelimab and Apatinib as the perioperative treatment in Patients With Biliary Tract Cancer.
- Being tested
- Adebrelimab, Apatinib, Gemcitabine, cisplatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adebrelimab, Apatinib, Gemcitabine, cisplatinDrug
Chemotherapy combined with Adebrelimab and Apatinib neoadjuvant therapy for 3 cycles before surgery, and Adebrelimab combined with Apatinib adjuvant therapy for 6 months after surgery
| Study group | Role | What they receive |
|---|---|---|
| treatment arm | Experimental | Not described Receives: Drug: Adebrelimab, Apatinib, Gemcitabine, cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-year EFS rate
1-year event-free survival rate
Measured: Up to approximately 3 years
Secondary outcomes (4)
R0 Resection rate
R0 Resection rate
Measured: Up to approximately 3 years
EFS
Event-free survival
Measured: Up to approximately 3 years
RFS
Recurrence-free survival
Measured: Up to approximately 3 years
OS
Overall survival
Measured: Up to approximately 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start1 Mar 2024
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resectable Intrahepatic Cholangiocarcinoma With High Risk of RecurrenceStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yajin Chen, Study director, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06280508
- Sponsor's protocol ID
- SYSKY-2024-082-01
- Status last verified
- Apr 2024
- First submitted
- 20 Feb 2024
- Last updated
- 23 Apr 2024
- Results posted
- 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 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-arm Exploratory Trail of Chemotherapy Combined With Adebrelimab and Apatinib as the Perioperative Treatment in Patients With Biliary Tract Cancer
- ClinicalTrials.gov ID
- NCT06280508
- Acronym / sponsor ID
- SYSKY-2024-082-01
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 28 Feb 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.
This is a prospective, single-arm exploratory study to evaluate the efficacy and safety of chemotherapy combined with Adebrelimab and Apatinib as the perioperative treatment in Patients With Biliary Tract Cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment arm | Experimental | Drug: Adebrelimab, Apatinib, Gemcitabine, cisplatin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- confirmed intrahepatic cholangiocarcinoma
- with Resectable tumor lesion
- no contraindications to surgery
- with high risk of tumour recurrence
- No prior systemic therapy for intrahepatic cholangiocarcinoma.
Key exclusion criteria (6 listed)
- History of gastrointestinal hemorrhage within 6 months prior to the start of study treatment or clear tendency of gastrointestinal hemorrhage
- Abdominal fistula, gastrointestinal perforation or intraperitoneal abscess within 6 months prior to the start of study treatment
- Known genetic or acquired hemorrhage or thrombotic tendency
- Thrombosis or thromboembolic event within 6 months prior to the start of study treatment
- Cardiac clinical symptom or disease that is not well controlled
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 |
|---|---|---|
| Adebrelimab, Apatinib, Gemcitabine, cisplatinChemotherapy combined with Adebrelimab and Apatinib neoadjuvant therapy for 3 cycles before surgery, and Adebrelimab combined with Apatinib adjuvant therapy for 6 months after surgery | Drug | treatment arm |
Primary outcome
1-year EFS rate
Time frame: Up to approximately 3 years
1-year event-free survival rate
4 secondary outcomes
R0 Resection rate
Time frame: Up to approximately 3 years
EFS
Time frame: Up to approximately 3 years
RFS
Time frame: Up to approximately 3 years
OS
Time frame: Up to approximately 3 years
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 23 Apr 2024.
- Individual participant dataSharing planned: No
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.
Yajin Chen study director
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Adebrelimab, Apatinib, Gemcitabine, cisplatin in people with Resectable Intrahepatic Cholangiocarcinoma With High Risk of Recurrence, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen 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 7 inclusion and 6 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 23 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 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 Yajin Chen (13719006202, cyj0509@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-year EFS rate (time frame: Up to approximately 3 years). 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 23 Apr 2024; AzTrials last refreshed its copy on 26 Oct 2026.