CholangiocarcinomaNCT06718257
Chemotherapy Combined with Immunotherapy and Targeted Therapy in Cholangiocarcinoma
An observational study of Cholangiocarcinoma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
This study aims to validate the efficacy and safety of GP/GEMOX combined with PD-1/L1 inhibitors and TKI agents in patients with advanced cholangiocarcinoma through a multicenter, retrospective study to guide clinical practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholangiocarcinoma
- What is being tested?
- Gemcitabine combined with cisplatin or oxaliplatin and Gemcitabine combined with cisplatin or oxaliplatin, PD-1/L1 and TKI inhibitors
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2024to 31 May 2025
- Phase
- Observational
- 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
Study population: Patients were histologically or radiologically confirmed intrahepatic cholangiocarcinoma, with initial treatment consisting of GP/GEMOX or GP/GEMOX combined with PD-1/L1 and TKI inhibitors.
Who may be able to join
- Histologically or radiologically confirmed intrahepatic cholangiocarcinoma
- Initially treated with GP/GEMOX or GP/GEMOX combined with PD-1/L1 and TKI inhibitors
Who cannot join
- Direct surgery after hospitalization
- Initial treatment combined with local therapies (radiotherapy, radiofrequency, particle implantation, TACE, etc.)
- Initial treatment involving other comprehensive therapeutic regimens
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
2nd Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310009
Weilin Wang, PHD, +86 057187783820, wam@zju.edu.cn
Yuan Ding, PHD, +86 18858101960, dingyuan@zju.edu
About this study
Official title: Chemotherapy Combined with Immunotherapy and Targeted Therapy in Advanced Intrahepatic Cholangiocarcinoma
This study aims to validate the efficacy and safety of GP/GEMOX combined with PD-1/L1 inhibitors and TKI agents in patients with advanced cholangiocarcinoma through a multicenter, retrospective study to guide clinical practice.
Read the detailed description
This study plans to enroll patients diagnosed with advanced cholangiocarcinoma. After confirming patients treated with GP/GEMOX or GP/GEMOX combined with PD-1/L1 and TKI agents as initial therapy, the investigators will collect relevant clinical data, including basic clinical information, laboratory data, imaging data, pathological data, and surgical data through an electronic medical record system.
- Conditions
- Cholangiocarcinoma
- Being tested
- Gemcitabine combined with cisplatin or oxaliplatin, Gemcitabine combined with cisplatin or oxaliplatin, PD-1/L1 and TKI inhibitors
- Keywords
- advanced cholangiocarcinoma, chemotherapy combined with immunotherapy and targeted therapy, clinical efficacy and safety
- Medical subject headings
- Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gemcitabine combined with cisplatin or oxaliplatinDrug
Gemcitabine (1000 mg/m², day 1 and 8) and cisplatin (75 mg/m², day 1) or oxaliplatin (85 mg/m², day 1)
Gemcitabine combined with cisplatin or oxaliplatin, PD-1/L1 and TKI inhibitorsDrug
Gemcitabine (1000 mg/m², day 1 and 8), cisplatin (75 mg/m²; day 1) or oxaliplatin (85 mg/m²; day 1), PD-1/L1 agents (200 mg; day 1), and TKI inhibitors (8 mg; per day)
| Study group | Role | What they receive |
|---|---|---|
| Control group | Patients initially received GP/GEMOX regimen. Receives: Drug: Gemcitabine combined with cisplatin or oxaliplatin | |
| Experimental group | Patients initially received GP/GEMOX combined with PD-1/L1 and TKI inhibitors regimen. Receives: Drug: Gemcitabine combined with cisplatin or oxaliplatin, PD-1/L1 and TKI inhibitors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
Overall survival (OS) is defined as the time from cancer diagnosis to death from any cause.
Measured: 1 year
Secondary outcomes (1)
Progression-free survival (PFS)
Progression-free survival (PFS) is defined as the time from the start of treatment until disease progression or the emergence of new lesions.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2024
- Study start1 Sep 2024
- Primary completion31 Mar 2025 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholangiocarcinomaStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Weilin Wang, PHD, Study chair, Department of Hepatobiliary and Pancreatic Surgery, Second Affiliated Hospital, School of Medicine, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06718257
- Sponsor's protocol ID
- 2024-1058
- Status last verified
- Nov 2024
- First submitted
- 2 Dec 2024
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chemotherapy Combined with Immunotherapy and Targeted Therapy in Advanced Intrahepatic Cholangiocarcinoma
- ClinicalTrials.gov ID
- NCT06718257
- Acronym / sponsor ID
- 2024-1058
- Conditions
- Cholangiocarcinoma
- Keywords
- advanced cholangiocarcinoma, chemotherapy combined with immunotherapy and targeted therapy, clinical efficacy and safety
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 5 Dec 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 study aims to validate the efficacy and safety of GP/GEMOX combined with PD-1/L1 inhibitors and TKI agents in patients with advanced cholangiocarcinoma through a multicenter, retrospective study to guide clinical practice.
Detailed description
This study plans to enroll patients diagnosed with advanced cholangiocarcinoma. After confirming patients treated with GP/GEMOX or GP/GEMOX combined with PD-1/L1 and TKI agents as initial therapy, the investigators will collect relevant clinical data, including basic clinical information, laboratory data, imaging data, pathological data, and surgical data through an electronic medical record system.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | – | Drug: Gemcitabine combined with cisplatin or oxaliplatinPatients initially received GP/GEMOX regimen. |
| Experimental group | – | Drug: Gemcitabine combined with cisplatin or oxaliplatin, PD-1/L1 and TKI inhibitorsPatients initially received GP/GEMOX combined with PD-1/L1 and TKI inhibitors regimen. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients were histologically or radiologically confirmed intrahepatic cholangiocarcinoma, with initial treatment consisting of GP/GEMOX or GP/GEMOX combined with PD-1/L1 and TKI inhibitors.
Key inclusion criteria (2 listed)
- Histologically or radiologically confirmed intrahepatic cholangiocarcinoma
- Initially treated with GP/GEMOX or GP/GEMOX combined with PD-1/L1 and TKI inhibitors
Key exclusion criteria (3 listed)
- Direct surgery after hospitalization
- Initial treatment combined with local therapies (radiotherapy, radiofrequency, particle implantation, TACE, etc.)
- Initial treatment involving other comprehensive therapeutic regimens
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 |
|---|---|---|
| Gemcitabine combined with cisplatin or oxaliplatinGemcitabine (1000 mg/m², day 1 and 8) and cisplatin (75 mg/m², day 1) or oxaliplatin (85 mg/m², day 1) | Drug | Control group |
| Gemcitabine combined with cisplatin or oxaliplatin, PD-1/L1 and TKI inhibitorsGemcitabine (1000 mg/m², day 1 and 8), cisplatin (75 mg/m²; day 1) or oxaliplatin (85 mg/m²; day 1), PD-1/L1 agents (200 mg; day 1), and TKI inhibitors (8 mg; per day) | Drug | Experimental group |
Primary outcome
Overall survival (OS)
Time frame: 1 year
Overall survival (OS) is defined as the time from cancer diagnosis to death from any cause.
1 secondary outcome
Progression-free survival (PFS)
Time frame: 1 year
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 6 Feb 2025.
- 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.
Weilin Wang, PHD study chair
Department of Hepatobiliary and Pancreatic Surgery, Second Affiliated Hospital, School of Medicine, Zhejiang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cholangiocarcinoma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 2 inclusion and 3 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 6 Feb 2025. 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.
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 Weilin Wang, PHD (+86 057187783820, wam@zju.edu.cn), 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: 1 year). 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 6 Feb 2025.