Advanced Esophageal Squamous Cell CancerPhase 2NCT03732508
SHR-1316 in Combination With Chemotherapy in Patients With Esophageal Squamous Cell Cancer
A Phase 2 study testing Irinotecan liposome, SHR-1316 and Fluorouracil in people with Advanced Esophageal Squamous Cell Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study is to evaluate the progression-free survival (PFS) of Chemotherapy combined with SHR-1316 in patients with advanced esophageal squamous cell cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Esophageal Squamous Cell Cancer
- What is being tested?
- Irinotecan liposome, SHR-1316 and Fluorouracil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Nov 2018to Oct 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
- Histologically or cytologically confirmed unresectable local advanced/recurrent or metastasis esophageal squamous cell carcinoma;
- No previous systemic anti-tumor treatment;
- Subjects must have at least one measurable tumor lesion per RECIST 1.1;
- ECOG: 0-1;
- Adequate organ and bone marrow function;
Who cannot join
- Allergic to monoclonal antibodies, any SHR-1316 components,Irinotecan , Fluorouracil ;
- Prior therapy as follow:
- Anti-PD-1 or anti-PD-L1;
- Any experimental drugs within 4 weeks of the first dose of study medication;
- Received major operations or serious injuries within 4 weeks of the first dose of study medication;
- Received last dose of anticancer therapy (including chemotherapy, radiotherapy, targeted therapy, etc.) within 4 weeks of the first dose of study medication;
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- Not recovered to ≤CTCAE 1 from adverse events (except for hair loss) due to a previously anti-tumor treatment;
- Subjects with any active autoimmune disease or history of autoimmune disease;
- Pregnancy or breast feeding;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer Institute and Hospital,Chinese Academy of Medical Science
Beijing, Beijing Municipality, 100000
Jing Huang
About this study
Official title: SHR-1316, a Novel Anti-PD-L1 Antibody, in Combination With Irinotecan Liposome and Fluorouracil in Patients With Esophageal Squamous Cell Cancer: a Phase II Study
The purpose of this study is to evaluate the progression-free survival (PFS) of Chemotherapy combined with SHR-1316 in patients with advanced esophageal squamous cell cancer.
- Conditions
- Advanced Esophageal Squamous Cell Cancer
- Being tested
- Irinotecan liposome, SHR-1316, Fluorouracil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Irinotecan liposomeDrug
Irinotecan liposome intravenous infusion will be administered during the first day of treatment.
SHR-1316Drug
SHR-1316 intravenous infusion will be administered during the first day of treatment.
FluorouracilDrug
Fluorouracil intravenous infusion will be administered during the first day of treatment.
| Study group | Role | What they receive |
|---|---|---|
| Irinotecan liposome plus SHR1316 plus fluorouracil | Experimental | Not described Receives: Drug: Irinotecan liposome; Drug: SHR-1316; Drug: Fluorouracil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of Progression-Free Survival (PFS)
based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)
Measured: approximately 22 months
Secondary outcomes (4)
Disease Control Rate(DCR)
based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)
Measured: approximately 22 months
Objective Response Rate(ORR)
based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)
Measured: approximately 22 months
Overall Survival(OS)
OS is defined as the time from registration to death due to any cause, or censored at date last known alive.
Measured: approximately 22 months
Adverse Events(AE)
adverse events
Measured: approximately 22 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2018
- Study startNov 2018 (estimated)
- Primary completionNov 2019 (estimated)
- Study completionOct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Esophageal Squamous Cell CancerStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The 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
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jing Huang, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03732508
- Sponsor's protocol ID
- IRI-SHR-1316-201
- Status last verified
- Oct 2018
- First submitted
- 31 Oct 2018
- Last updated
- 6 Nov 2018
- Results posted
- No
- Data monitoring committee
- 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 6 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SHR-1316, a Novel Anti-PD-L1 Antibody, in Combination With Irinotecan Liposome and Fluorouracil in Patients With Esophageal Squamous Cell Cancer: a Phase II Study
- ClinicalTrials.gov ID
- NCT03732508
- Acronym / sponsor ID
- IRI-SHR-1316-201
- Conditions
- Advanced Esophageal Squamous Cell Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Nov 2018 (estimated)
- Primary completion
- Nov 2019 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 6 Nov 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.
The purpose of this study is to evaluate the progression-free survival (PFS) of Chemotherapy combined with SHR-1316 in patients with advanced esophageal squamous cell cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Irinotecan liposome plus SHR1316 plus fluorouracil | Experimental | Drug: Irinotecan liposome, Drug: SHR-1316, Drug: Fluorouracil |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically or cytologically confirmed unresectable local advanced/recurrent or metastasis esophageal squamous cell carcinoma;
- No previous systemic anti-tumor treatment;
- Subjects must have at least one measurable tumor lesion per RECIST 1.1;
- ECOG: 0-1;
- Adequate organ and bone marrow function;
Key exclusion criteria (9 listed)
- Allergic to monoclonal antibodies, any SHR-1316 components,Irinotecan , Fluorouracil ;
- Prior therapy as follow:
- Not recovered to ≤CTCAE 1 from adverse events (except for hair loss) due to a previously anti-tumor treatment;
- Subjects with any active autoimmune disease or history of autoimmune disease;
- Pregnancy or breast feeding;
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 |
|---|---|---|
| Irinotecan liposomeIrinotecan liposome intravenous infusion will be administered during the first day of treatment. | Drug | Irinotecan liposome plus SHR1316 plus fluorouracil |
| SHR-1316SHR-1316 intravenous infusion will be administered during the first day of treatment. | Drug | Irinotecan liposome plus SHR1316 plus fluorouracil |
| FluorouracilFluorouracil intravenous infusion will be administered during the first day of treatment. | Drug | Irinotecan liposome plus SHR1316 plus fluorouracil |
Primary outcome
Duration of Progression-Free Survival (PFS)
Time frame: approximately 22 months
based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)
4 secondary outcomes
Disease Control Rate(DCR)
Time frame: approximately 22 months
Objective Response Rate(ORR)
Time frame: approximately 22 months
Overall Survival(OS)
Time frame: approximately 22 months
Adverse Events(AE)
Time frame: approximately 22 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2018.
- 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.
Jing Huang principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
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 Irinotecan liposome, SHR-1316 and Fluorouracil in people with Advanced Esophageal Squamous Cell Cancer, run by Jiangsu HengRui Medicine Co., Ltd. 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 5 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: status not confirmed, as of the sponsor's last update on 6 Nov 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fei Shi (+86-18036618733, hrshifei@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of Progression-Free Survival (PFS) (time frame: approximately 22 months). 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 Nov 2018; AzTrials last refreshed its copy on 7 Nov 2026.