Biliary Tract Cancer (BTC)Phase 1/2NCT04004234
A Phase I/II Study of the Pan-immunotherapy in Patients With Local Advanced/Metastatic BTC
A Phase 1/2 study testing Manganese Chloride, nab-paclitaxel and Gemcitabine in people with Biliary Tract Cancer (BTC), run by Chinese PLA General Hospital at 1 site in China.
Trial summary
Biliary tract cancer (BTC) is a rare heterogeneous collection of malignancies arising within the biliary tract, characterized by innate chemoresistance and abysmal prognosis. PD-1 blockade has been developed to a new class of cancer immunotherapy that could restore an adequate immunosurveillance against the neoplasm… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Biliary Tract Cancer (BTC)
- What is being tested?
- Manganese Chloride, nab-paclitaxel and Gemcitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2019to 31 Aug 2021
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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
- ≥ 18 years old.
- Life expectancy of at least 3 months.
- Subjects must have Histopathological/cytological diagnosis of unresectable or recurrent /metastatic biliary tract carcinoma (intra-hepatic, extrahepatic or gall bladder).
- Eastern Cooperative Oncology Group performance status 0-2.
- Subjects must have at least one measurable lesion ≥ 1 cm as defined by response criteria.
- Subjects may have received prior radiotherapy, chemotherapy, or other local ablative therapies, which completed ≥ 4 weeks prior to registration AND patient has recovered to <= grade 1 toxicity.
Show all 9Show fewer
- Subjects with Anti-PD-1 antibody treatment history are eligible which must be resistance.
- Adequate organ function.
- Participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study drug.
Who cannot join
- Subjects with any autoimmune disease or history of syndrome that requires corticosteroids or immunosuppressive medications.
- Serious uncontrolled medical disorders or active infections, pulmonary infection especially.
- Prior organ allograft.
- Women who are pregnant or breastfeeding.
- Women with a positive pregnancy test on enrollment or prior to investigational product administration.
- Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Biotherapeutic Department of Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
Weidong Han, M.D, +86-10-66937463, hanwdrsw@sina.com
Qingming Yang, M.D, +86-10-55499341, yangqm301@163.com
About this study
Official title: A Phase I/II, Open-label, Single-center Study to Evaluate the Safety and Efficacy of the Pan-immunotherapy in Subjects With Local Advanced/Metastatic Biliary Tract Cancer
Biliary tract cancer (BTC) is a rare heterogeneous collection of malignancies arising within the biliary tract, characterized by innate chemoresistance and abysmal prognosis. PD-1 blockade has been developed to a new class of cancer immunotherapy that could restore an adequate immunosurveillance against the neoplasm and enhance T-cell-mediated anticancer immune responses. Manganese has been confirmed to activate antigen-presenting cells and function as mucosal immunoadjuvants in pre-clinical studies. This open-label, phase I/II study is designed to assess the safety and efficacy of Manganese primed combined therapy of anti-PD-1 antibody and gemcitabine/cisplatin chemotherapy.
- Conditions
- Biliary Tract Cancer (BTC)
- Being tested
- Manganese Chloride, nab-paclitaxel, Gemcitabine, anti-PD-1 antibody
- Keywords
- local advanced, metastatic, anti-PD-1 antibody, Manganese, gemcitabine, cisplatin
- Medical subject headings
- Biliary Tract Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manganese ChlorideDrug
Administered by inhalation at 0.2 or 0.4mg/kg/d once daily in a 3-week cycle
nab-paclitaxelDrug
Also called Paclitaxel For Injection (Albumin Bound)
Administered intravenously, 125mg/m2/d on day1 and day8 in a 3-week cycle
GemcitabineDrug
Administered intravenously, 1g/m2/d on day1 and day8 in a 3-week cycle
anti-PD-1 antibodyDrug
Also called Anti-PD-1 monoclonal antibody; PD-1 inhibitor
Administered intravenously, 2-4mg/kg on day 3 in a 3-week cycle
| Study group | Role | What they receive |
|---|---|---|
| Manganese primed anti-PD-1 antibody plus nPG chemotherapy | Experimental | Subject received Manganese primed anti-PD-1 antibody, nab-paclitaxel and gemcitabine every 3 weeks until achieving a second assessable stable disease or up to a maximum of 12 cycles. Treatment continued until progressive disease, development of unacceptable toxicity, or withdrawal of consent. Receives: Drug: Manganese Chloride; Drug: nab-paclitaxel; Drug: Gemcitabine; Drug: anti-PD-1 antibody |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects with treatment-related adverse events (AEs)
Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v5.0. AEs were considered to be treatment-related if they had started or worsened within the interval from first study drug administration until the follow-up visit.
Measured: 12 months
Progression-free survival (PFS) at 6 months
Progression free survival (PFS) at 6 months in patients with local advanced /metastatic BTCs treated with the combined regimen. Progression will be defined clinically or on imaging as per immune related response evaluation criteria in solid tumors (RECIST V1.1) definition
Measured: 6 months
Secondary outcomes (4)
Disease control rate (DCR)
DCR is defined as the proportion of subjects who achieved a stable disease (SD), partial response (PR) or complete response (CR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Measured: 12 months
Object response rate (ORR)
ORR is defined as the proportion of subjects who achieved a partial response (PR) or complete response (CR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Measured: 12 months
Overall survival (OS)
OS time was measured from the study entry to the date of death.
Measured: 24 months
Number of participants with laboratory test abnormalities
The laboratory tests of serum cytokines and chemokines will be performed on day 1 and 3 of each cycle, and the abnormality will be determined by the investigator.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2019
- Study start1 Mar 2019
- Primary completion31 Aug 2020 (estimated)
- Study completion31 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary Tract Cancer (BTC)Studies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Han weidong, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04004234
- Sponsor's protocol ID
- CHN-PLAGH-BT-042
- Status last verified
- Jul 2019
- First submitted
- 28 Jun 2019
- Last updated
- 9 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II, Open-label, Single-center Study to Evaluate the Safety and Efficacy of the Pan-immunotherapy in Subjects With Local Advanced/Metastatic Biliary Tract Cancer
- ClinicalTrials.gov ID
- NCT04004234
- Acronym / sponsor ID
- CHN-PLAGH-BT-042
- Conditions
- Biliary Tract Cancer (BTC)
- Keywords
- local advanced, metastatic, anti-PD-1 antibody, Manganese, gemcitabine, cisplatin
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 31 Aug 2020 (estimated)
- Study completion
- 31 Aug 2021 (estimated)
- First posted
- 1 Jul 2019 (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.
Biliary tract cancer (BTC) is a rare heterogeneous collection of malignancies arising within the biliary tract, characterized by innate chemoresistance and abysmal prognosis. PD-1 blockade has been developed to a new class of cancer immunotherapy that could restore an adequate immunosurveillance against the neoplasm and enhance T-cell-mediated anticancer immune responses. Manganese has been confirmed to activate antigen-presenting cells and function as mucosal immunoadjuvants in pre-clinical studies. This open-label, phase I/II study is designed to assess the safety and efficacy of Manganese primed combined therapy of anti-PD-1 antibody and gemcitabine/cisplatin chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Manganese primed anti-PD-1 antibody plus nPG chemotherapy | Experimental | Drug: Manganese Chloride, Drug: nab-paclitaxel, Drug: Gemcitabine, Drug: anti-PD-1 antibodySubject received Manganese primed anti-PD-1 antibody, nab-paclitaxel and gemcitabine every 3 weeks until achieving a second assessable stable disease or up to a maximum of 12 cycles. Treatment continued until progressive disease, development of unacceptable toxicity, or withdrawal of consent. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- ≥ 18 years old.
- Life expectancy of at least 3 months.
- Subjects must have Histopathological/cytological diagnosis of unresectable or recurrent /metastatic biliary tract carcinoma (intra-hepatic, extrahepatic or gall bladder).
- Eastern Cooperative Oncology Group performance status 0-2.
- Subjects must have at least one measurable lesion ≥ 1 cm as defined by response criteria.
Key exclusion criteria (6 listed)
- Subjects with any autoimmune disease or history of syndrome that requires corticosteroids or immunosuppressive medications.
- Serious uncontrolled medical disorders or active infections, pulmonary infection especially.
- Prior organ allograft.
- Women who are pregnant or breastfeeding.
- Women with a positive pregnancy test on enrollment or prior to investigational product administration.
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 |
|---|---|---|
| Manganese ChlorideAdministered by inhalation at 0.2 or 0.4mg/kg/d once daily in a 3-week cycle | Drug | Manganese primed anti-PD-1 antibody plus nPG chemotherapy |
| nab-paclitaxelAlso: Paclitaxel For Injection (Albumin Bound)Administered intravenously, 125mg/m2/d on day1 and day8 in a 3-week cycle | Drug | Manganese primed anti-PD-1 antibody plus nPG chemotherapy |
| GemcitabineAdministered intravenously, 1g/m2/d on day1 and day8 in a 3-week cycle | Drug | Manganese primed anti-PD-1 antibody plus nPG chemotherapy |
| anti-PD-1 antibodyAlso: Anti-PD-1 monoclonal antibody; PD-1 inhibitorAdministered intravenously, 2-4mg/kg on day 3 in a 3-week cycle | Drug | Manganese primed anti-PD-1 antibody plus nPG chemotherapy |
Primary outcome
Number of Subjects with treatment-related adverse events (AEs)
Time frame: 12 months
Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v5.0. AEs were considered to be treatment-related if they had started or worsened within the interval from first study drug administration until the follow-up visit.
Progression-free survival (PFS) at 6 months
Time frame: 6 months
Progression free survival (PFS) at 6 months in patients with local advanced /metastatic BTCs treated with the combined regimen. Progression will be defined clinically or on imaging as per immune related response evaluation criteria in solid tumors (RECIST V1.1) definition
4 secondary outcomes
Disease control rate (DCR)
Time frame: 12 months
Object response rate (ORR)
Time frame: 12 months
Overall survival (OS)
Time frame: 24 months
Number of participants with laboratory test abnormalities
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2019.
Related trials for Biliary Tract Cancer (BTC)
RecruitingPhase 2
Gemcitabine, Cisplatin, Nab-paclitaxel (GAP) and Cemiplimab for Locally Advanced Biliary Tract Cancer (BTC)
Colon and Rectal Cancer
RecruitingPhase 2
A Study to Learn More About How Well Treatment With Sevabertinib (BAY 2927088) Tablets Works and How Safe it is in Participants Who Have a Solid Tumor With Mutations of the Human Epidermal Growth Factor Receptor 2 (HER2)
Advanced Solid Tumors, HER2 Mutation
RecruitingPhase 3
D07001 Softgel-Capsules and Capecitabine Combination Therapy in Patients With Advanced Biliary Tract Cancer
Biliary Tract Cancer (BTC)
Not yet recruitingPhase 2
Daraxonrasib in Asian RAS-mutant Biliary Tract Cancer
Biliary Tract Cancer (BTC)
Not yet recruiting
Prospective AI-Assisted Screening of Biliary Tract Cancer Using Non-Contrast CT
Biliary Tract Cancer (BTC)
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Manganese Chloride, nab-paclitaxel and Gemcitabine in people with Biliary Tract Cancer (BTC), run by Chinese PLA General Hospital 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 9 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: status not confirmed, as of the sponsor's last update on 9 Jul 2019. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Weidong Han (86(10)66937463, hanwdrsw@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects with treatment-related adverse events (AEs) (time frame: 12 months). The study lists 2 primary outcomes in all. 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 9 Jul 2019.