Biliary Tract NeoplasmsPhase 2ModifiedNCT06037655
Chemotherapy Combined With Adebrelimab and Mecapegfilgrastim in Neoadjuvant Treatment of Potentially Resectable BTC
A Phase 2 study testing Total Neoadjuvant Treatment in people with Biliary Tract Neoplasms, run by The First Affiliated Hospital with Nanjing Medical University.
Trial summary
The purpose of this study is to assess the safety and efficacy of Gemcitabine/cisplatin combined with Adebrelimab and Mecapegfilgrastim in neoadjuvant treatment of potentially resectable Biliary Tract Neoplasms. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Biliary Tract Neoplasms
- What is being tested?
- Total Neoadjuvant Treatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 25 Sep 2023to 31 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
- Male or female
- Age ≥ 18 years，≤ 75 years
- Patients with untreated resectable locally advanced biliary tract cancer (BTC) who are difficult to directly resecte surgically
- Ability to provide written informed consent prior to participation in any study-related procedure
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- At least one, not previously irradiated, measurable lesion according to RECIST (version 1.1).
- Adequate organ function
Who cannot join
- Diagnosis of mixed ampullary, hepatocellular, and cholangiocarcinoma
- Known history of a serious allergy to any monoclonal antibody
- Any active malignancy prior to the start of treatment
- Active or history of autoimmune disease
- Other acute or chronic conditions, psychiatric disorders, or laboratory abnormalities that may increase the risk of study participation
- Pregnant or lactating women
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Xiaofeng Chen contact
About this study
Official title: Gemcitabine/Cisplatin Combined With Adebrelimab and Mecapegfilgrastim in Neoadjuvant Treatment of Potentially Resectable Biliary Tract Carcinoma, A Single-arm Study
The purpose of this study is to assess the safety and efficacy of Gemcitabine/cisplatin combined with Adebrelimab and Mecapegfilgrastim in neoadjuvant treatment of potentially resectable Biliary Tract Neoplasms.
Read the detailed description
After being informed about the study and potential risks, patients giving written informed consent will undergo a 1-week screening period to determine eligibility for study entry. At week 0, patients who meet the eligibility requirements will be receive Gemcitabine/cisplatin combined with Adebrelimab and Mecapegfilgrastim three weeks a cycle, surgery was performed after 4 cycles.
- Conditions
- Biliary Tract Neoplasms
- Being tested
- Total Neoadjuvant Treatment
- 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.
Total Neoadjuvant TreatmentDrug
Adebrelimab (1200 mg) every three weeks intravenously; Mecapegfilgrastim (6 mg) every three weeks intravenously; Gemcitabine (1000 mg/m2) every three weeks on days 1 and 8 intravenously; Cisplatin (25 mg/m2) every three weeks on days 1 and 8 intravenously
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | NeoAdjuvant Therapy with Adebrelimab plus Mecapegfilgrastim and Gemcitabine/cisplatin followed by the operation Receives: Drug: Total Neoadjuvant Treatment |
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 patients achieving clinical complete response (CR) or partial response (PR) according to RECIST v1.1
Measured: 18 weeks
Secondary outcomes (1)
overall survival (OS)
Overall survival
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2023
- Study start25 Sep 2023 (estimated)
- Primary completion31 Mar 2026 (estimated)
- Study completion31 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 NeoplasmsStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical 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
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiangcheng Li, Study chair, The First Affiliated Hospital with Nanjing Medical UniversityXiaofeng Chen, Principal investigator, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06037655
- Sponsor's protocol ID
- MA-BTC-II-002
- Acronym
- Modified
- Status last verified
- Sep 2023
- First submitted
- 7 Sep 2023
- Last updated
- 14 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gemcitabine/Cisplatin Combined With Adebrelimab and Mecapegfilgrastim in Neoadjuvant Treatment of Potentially Resectable Biliary Tract Carcinoma, A Single-arm Study
- ClinicalTrials.gov ID
- NCT06037655
- Acronym / sponsor ID
- Modified / MA-BTC-II-002
- Conditions
- Biliary Tract Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 25 Sep 2023 (estimated)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 14 Sep 2023 (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 purpose of this study is to assess the safety and efficacy of Gemcitabine/cisplatin combined with Adebrelimab and Mecapegfilgrastim in neoadjuvant treatment of potentially resectable Biliary Tract Neoplasms.
Detailed description
After being informed about the study and potential risks, patients giving written informed consent will undergo a 1-week screening period to determine eligibility for study entry. At week 0, patients who meet the eligibility requirements will be receive Gemcitabine/cisplatin combined with Adebrelimab and Mecapegfilgrastim three weeks a cycle, surgery was performed after 4 cycles.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: Total Neoadjuvant TreatmentNeoAdjuvant Therapy with Adebrelimab plus Mecapegfilgrastim and Gemcitabine/cisplatin followed by the operation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female
- Age ≥ 18 years，≤ 75 years
- Patients with untreated resectable locally advanced biliary tract cancer (BTC) who are difficult to directly resecte surgically
- Ability to provide written informed consent prior to participation in any study-related procedure
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Key exclusion criteria (6 listed)
- Diagnosis of mixed ampullary, hepatocellular, and cholangiocarcinoma
- Known history of a serious allergy to any monoclonal antibody
- Any active malignancy prior to the start of treatment
- Active or history of autoimmune disease
- Other acute or chronic conditions, psychiatric disorders, or laboratory abnormalities that may increase the risk of study participation
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 |
|---|---|---|
| Total Neoadjuvant TreatmentAdebrelimab (1200 mg) every three weeks intravenously; Mecapegfilgrastim (6 mg) every three weeks intravenously; Gemcitabine (1000 mg/m2) every three weeks on days 1 and 8 intravenously; Cisplatin (25 mg/m2) every three weeks on days 1 and 8 intravenously | Drug | Experimental |
Primary outcome
Objective response rate (ORR)
Time frame: 18 weeks
ORR is defined as patients achieving clinical complete response (CR) or partial response (PR) according to RECIST v1.1
1 secondary outcome
overall survival (OS)
Time frame: 2 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 14 Sep 2023.
- Individual participant dataSharing planned: No
Related trials for Biliary Tract Neoplasms
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.
Xiaofeng Chen contact
Xiangcheng Li study chair
The First Affiliated Hospital with Nanjing Medical University
Xiaofeng Chen principal investigator
The First Affiliated Hospital with Nanjing Medical University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Total Neoadjuvant Treatment in people with Biliary Tract Neoplasms, run by The First Affiliated Hospital with Nanjing Medical 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 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: opening soon, as of the sponsor's last update on 14 Sep 2023. 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 Xiangcheng Li (18951999088, drlixc@163.com), 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: 18 weeks). 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 Sep 2023.