Biliary Tract CancerPhase 2NCT03486678
SHR-1210 in Combination With GEMOX in Patients With Advanced BTC
A Phase 2 study testing SHR-1210+GEMOX in people with Biliary Tract Cancer and Cholangiocarcinoma, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
This is a single-arm, open-label and exploratory clinical study of PD-1 monoclonal antibody SHR-1210 combined with GEMOX regimen (gemcitabine combined oxaliplatin) in the treatment of advanced biliary malignancies. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Biliary Tract Cancer, Cholangiocarcinoma
- What is being tested?
- SHR-1210+GEMOX
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteChina
- Study dates
- 10 Feb 2018to 30 Nov 2020
- Phase
- Phase 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
- Pathology confirmed biliary malignancy, including intrahepatic bile duct carcinoma, extrahepatic bile duct carcinoma, and gallbladder carcinoma.
- Age:18-75 years, male or female.
- The estimated survival period is more than 3 months.
- ECOG 0-1.
- There is at least one measurable lesion, according to the RECIST 1.1 standard.
- Patients has not been treated by oxaliplatin, gemcitabine and pd-1 / pd-l1 antibody.
- Patients who have been treated tegafur or capecitabine as adjuvant chemotherapy or first-line treatment may be selected.
Who cannot join
- There were concurrent malignant tumors, except for the cured skin basal cell carcinoma and cervical carcinoma in situ.
- Other drug clinical trials have been taken in four weeks.
- Patients with a history of central nervous system metastasis or central nervous system metastasis are known before the screening.
- Patients with a history of unstable angina.
- The urine routine indicated that the urine protein was greater than ++ and confirmed the 24-hour urine protein quantification >1.0 g.
- Have used immune-targeted therapy drugs.
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- The patient had received a liver transplant.
- Having a history of chronic autoimmune diseases such as systemic lupus erythematosus.
- Having a history of immunodeficiency, or other acquired, congenital immunodeficiency diseases, or a history of organ transplantation;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-arm, Open-label and Exploratory Clinical Study of PD-1 Monoclonal Antibody SHR-1210 in Combination With GEMOX (Gemcitabine Combined Oxaliplatin) in Patients With Advanced Biliary Tract Cancer
This is a single-arm, open-label and exploratory clinical study of PD-1 monoclonal antibody SHR-1210 combined with GEMOX regimen (gemcitabine combined oxaliplatin) in the treatment of advanced biliary malignancies.
In oder to observe and evaluate the efficacy and safety of PD-1 antibody SHR-1210 combined with GEMOX in the treatment of patients with advanced biliary malignant tumor (BTC),subjects with pathological confirmed biliary cancer, including intrahepatic bile duct carcinoma, extrahepatic bile duct carcinoma, and gallbladder carcinoma will be enrolled.
28 days as a treatment cycle, SHR-1210 3mg/kg and Gemcitabine 800 mg/m2 will be administered IV Q2W (D1 and D15 of a treatment cycle),and Oxaliplatin 85mg/m2 will be administered IV Q2W (D2 and D16 of a treatment cycle). PD-1 antibody combined chemotherapy will be used up to 6 cycles.SHR-1210 3mg/kg IV Q2W will be administered beyond 6 cycles chemotherapy until disease progression or un-tolerable toxicity.
- Conditions
- Biliary Tract Cancer, Cholangiocarcinoma
- Being tested
- SHR-1210+GEMOX
- Keywords
- BTC, PD-1 antibody
- Medical subject headings
- Biliary Tract Neoplasms, Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-1210+GEMOXDrug
28 days as a treatment cycle, SHR-1210 3mg/kg and Gemcitabine 800 mg/m2 will be administered IV Q2W (D1 and D15 of a treatment cycle),and Oxaliplatin 85mg/m2 will be administered IV Q2W (D2 and D16 of a treatment cycle). PD-1 antibody combined chemotherapy used up to 6 cycles.SHR-1210 3mg/kg IV Q2W will be administered beyond chemotherapy until the disease progression or untolerable toxicity.
| Study group | Role | What they receive |
|---|---|---|
| SHR1210+GEMOX | Experimental | This is a single arm trial. Participants will receive SHR1210 + GEMOX treatment. Receives: Drug: SHR-1210+GEMOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-month Progression Free Survival (PFS) rate
the rate of 6-month progression free survival
Measured: from the first drug administration up to 6 months
Incidence of Treatment-Emergent Adverse Events
Incidence of Treatment-Emergent Adverse Events, especially immune related adverse events
Measured: from the first drug administration to within 90 days for the last SHR-1210 dose
Secondary outcomes (5)
Objective Response Rate (ORR)
the best Objective Response Rate
Measured: from the first drug administration up to two years
Duration of response (DOR)
Duration of response
Measured: from the first drug administration up to two years
Disease Control Rate (DCR)
the Rate of Disease Control
Measured: from the first drug administration up to two years
12-month Overall survival (OS) rate
Overall Survival rate at 12 months
Measured: from the first drug administration up to approximately 12 months
OS
Overall survival
Measured: from the first drug administration up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2018
- Study start10 Feb 2018
- Primary completion1 Aug 2020
- Study completion30 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Biliary Tract CancerStudies 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
- 38 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Yongqian Shu, PhD, Principal investigator, JANGSU PROVINCE HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03486678
- Sponsor's protocol ID
- SHR1210-GEMOX-BTC-IIT03
- Status last verified
- Oct 2021
- First submitted
- 1 Feb 2018
- Last updated
- 28 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liu QP, Tang J, Chen YZ, Guo F, Ma L, Pan LL, Tian YT, Wu XF, Zhang YD, Chen XF. Immuno-genomic-radiomics to predict response of biliary tract cancer to camrelizumab plus GEMOX in a single-arm phase II trial. JHEP Rep. 2023 Apr 22;5(7):100763. doi: 10.1016/j.jhepr.2023.100763. eCollection 2023 Jul.
PubMed 37333974Chen X, Wang D, Liu J, Qiu J, Zhou J, Ying J, Shi Y, Wang Z, Lou H, Cui J, Zhang J, Liu Y, Zhao F, Pan L, Zhao J, Zhu D, Chen S, Li X, Li X, Zhu L, Shao Y, Shu Y. Genomic alterations in biliary tract cancer predict prognosis and immunotherapy outcomes. J Immunother Cancer. 2021 Nov;9(11):e003214. doi: 10.1136/jitc-2021-003214.
PubMed 34795005Chen X, Wu X, Wu H, Gu Y, Shao Y, Shao Q, Zhu F, Li X, Qian X, Hu J, Zhao F, Mao W, Sun J, Wang J, Han G, Li C, Xia Y, Seesaha PK, Zhu D, Li H, Zhang J, Wang G, Wang X, Li X, Shu Y. Camrelizumab plus gemcitabine and oxaliplatin (GEMOX) in patients with advanced biliary tract cancer: a single-arm, open-label, phase II trial. J Immunother Cancer. 2020 Nov;8(2):e001240. doi: 10.1136/jitc-2020-001240.
PubMed 33172881
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Open-label and Exploratory Clinical Study of PD-1 Monoclonal Antibody SHR-1210 in Combination With GEMOX (Gemcitabine Combined Oxaliplatin) in Patients With Advanced Biliary Tract Cancer
- ClinicalTrials.gov ID
- NCT03486678
- Acronym / sponsor ID
- SHR1210-GEMOX-BTC-IIT03
- Conditions
- Biliary Tract Cancer, Cholangiocarcinoma
- Keywords
- BTC, PD-1 antibody
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Study start
- 10 Feb 2018 (actual)
- Primary completion
- 1 Aug 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 3 Apr 2018 (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 single-arm, open-label and exploratory clinical study of PD-1 monoclonal antibody SHR-1210 combined with GEMOX regimen (gemcitabine combined oxaliplatin) in the treatment of advanced biliary malignancies.
In oder to observe and evaluate the efficacy and safety of PD-1 antibody SHR-1210 combined with GEMOX in the treatment of patients with advanced biliary malignant tumor (BTC),subjects with pathological confirmed biliary cancer, including intrahepatic bile duct carcinoma, extrahepatic bile duct carcinoma, and gallbladder carcinoma will be enrolled.
28 days as a treatment cycle, SHR-1210 3mg/kg and Gemcitabine 800 mg/m2 will be administered IV Q2W (D1 and D15 of a treatment cycle),and Oxaliplatin 85mg/m2 will be administered IV Q2W (D2 and D16 of a treatment cycle). PD-1 antibody combined chemotherapy will be used up to 6 cycles.SHR-1210 3mg/kg IV Q2W will be administered beyond 6 cycles chemotherapy until disease progression or un-tolerable toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SHR1210+GEMOX | Experimental | Drug: SHR-1210+GEMOXThis is a single arm trial. Participants will receive SHR1210 + GEMOX treatment. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Pathology confirmed biliary malignancy, including intrahepatic bile duct carcinoma, extrahepatic bile duct carcinoma, and gallbladder carcinoma.
- Age:18-75 years, male or female.
- The estimated survival period is more than 3 months.
- ECOG 0-1.
- There is at least one measurable lesion, according to the RECIST 1.1 standard.
Key exclusion criteria (9 listed)
- There were concurrent malignant tumors, except for the cured skin basal cell carcinoma and cervical carcinoma in situ.
- Other drug clinical trials have been taken in four weeks.
- Patients with a history of central nervous system metastasis or central nervous system metastasis are known before the screening.
- Patients with a history of unstable angina.
- The urine routine indicated that the urine protein was greater than ++ and confirmed the 24-hour urine protein quantification >1.0 g.
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-1210+GEMOX28 days as a treatment cycle, SHR-1210 3mg/kg and Gemcitabine 800 mg/m2 will be administered IV Q2W (D1 and D15 of a treatment cycle),and Oxaliplatin 85mg/m2 will be administered IV Q2W (D2 and D16 of a treatment cycle). PD-1 antibody combined chemotherapy used up to 6 cycles.SHR-1210 3mg/kg IV Q2W will be administered beyond chemotherapy until the disease progression or untolerable toxicity. | Drug | SHR1210+GEMOX |
Primary outcome
6-month Progression Free Survival (PFS) rate
Time frame: from the first drug administration up to 6 months
the rate of 6-month progression free survival
Incidence of Treatment-Emergent Adverse Events
Time frame: from the first drug administration to within 90 days for the last SHR-1210 dose
Incidence of Treatment-Emergent Adverse Events, especially immune related adverse events
5 secondary outcomes
Objective Response Rate (ORR)
Time frame: from the first drug administration up to two years
Duration of response (DOR)
Time frame: from the first drug administration up to two years
Disease Control Rate (DCR)
Time frame: from the first drug administration up to two years
12-month Overall survival (OS) rate
Time frame: from the first drug administration up to approximately 12 months
OS
Time frame: from the first drug administration up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2021.
- Derived from this study: PubMed 37333974Liu QP, Tang J, Chen YZ, Guo F, Ma L, Pan LL, Tian YT, Wu XF, Zhang YD, Chen XF. Immuno-genomic-radiomics to predict response of biliary tract cancer to camrelizumab plus GEMOX in a single-arm phase II trial. JHEP Rep. 2023 Apr 22;5(7):100763. doi: 10.1016/j.jhepr.2023.100763. eCollection 2023 Jul.
- Derived from this study: PubMed 34795005Chen X, Wang D, Liu J, Qiu J, Zhou J, Ying J, Shi Y, Wang Z, Lou H, Cui J, Zhang J, Liu Y, Zhao F, Pan L, Zhao J, Zhu D, Chen S, Li X, Li X, Zhu L, Shao Y, Shu Y. Genomic alterations in biliary tract cancer predict prognosis and immunotherapy outcomes. J Immunother Cancer. 2021 Nov;9(11):e003214. doi: 10.1136/jitc-2021-003214.
- Derived from this study: PubMed 33172881Chen X, Wu X, Wu H, Gu Y, Shao Y, Shao Q, Zhu F, Li X, Qian X, Hu J, Zhao F, Mao W, Sun J, Wang J, Han G, Li C, Xia Y, Seesaha PK, Zhu D, Li H, Zhang J, Wang G, Wang X, Li X, Shu Y. Camrelizumab plus gemcitabine and oxaliplatin (GEMOX) in patients with advanced biliary tract cancer: a single-arm, open-label, phase II trial. J Immunother Cancer. 2020 Nov;8(2):e001240. doi: 10.1136/jitc-2020-001240.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Yongqian Shu, PhD principal investigator
JANGSU PROVINCE HOSPITAL
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 SHR-1210+GEMOX in people with Biliary Tract Cancer and Cholangiocarcinoma, run by The First Affiliated Hospital with Nanjing Medical 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 9 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: finished, as of the sponsor's last update on 28 Oct 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-month Progression Free Survival (PFS) rate (time frame: from the first drug administration up to 6 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?
On the ClinicalTrials.gov record for NCT03486678, which also lists 3 linked publications.
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 Oct 2021.