Esophageal NeoplasmsPhase 2NCT03187314
Combination of Radiation Therapy and Anti-PD-1 Antibody SHR-1210 in Treating Patients With Esophageal Cancer
A Phase 2 study testing Radiation and SHR-1210 in people with Esophageal Neoplasms and Esophageal Diseases, run by Hangzhou Cancer Hospital at 1 site in China.
Trial summary
The objective of this study is to evaluate the efficacy and safety of radiation therapy combined with anti-PD-1 antibody SHR-1210 in patients with esophageal cancer Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Neoplasms, Esophageal Diseases, Esophageal Squamous Cell Carcinoma
- What is being tested?
- Radiation and SHR-1210
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- 14 Jun 2017to 30 Jun 2019
- 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
- age:18-75 years, male or femal.
- Histologically or cytologically confirmed Squamous Cell Carcinoma of the Esophagus, locally advanced, unresectable disease.
- Measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
- Can provide either a newly obtained or archival tumor tissue sample.
- ECOG 0-1.
- Life expectancy of greater than 12 weeks.
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- Adequate organ function.
- Female: child bearing potential, a negative urine or serum pregnancy test result within 72 h before study treatment. Participants of reproductive potential must be willing to use adequate contraception for the course of the study through 3 months after the last dose of SHR-1210.
- Patient has given written informed consent.
Who cannot join
- Patients who have or are currently undergoing additional chemotherapy, radiation therapy, targeted therapy or immunotherapy.
- Complete obstruction of the esophagus, or patients who have the potential to develop perforation
- Other malignancy within 5 years prior to entry into the study, expect for curatively treated basal cell and squamous cell carcinoma of the skin and/or curatively resected in-situ cervical and/or breast cancers.
- Known central nervous system (CNS) metastases.
- Subjects with any active autoimmune disease or history of autoimmune disease.
- Uncontrolled clinically significant heart disease, including but not limited to the following: (1) > NYHA II congestive heart failure; (2) unstable angina, (3) myocardial infarction within the past 1 year; (4) clinically significant supraventricular arrhythmia or ventricular arrhythmia requirement for treatment or intervention;
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- Active infection or an unexplained fever > 38.5°C during screening or before the first scheduled day of dosing (subjects with tumor fever may be enrolled at the discretion of the investigator);
- History of Interstitial Pneumonia or active non-infectious pneumonitis.
- Known Human Immunodeficiency Virus (HIV) infection、active Hepatitis B or Hepatitis C.
- Prior therapy with a PD-1, anti-PD-Ligand 1 (PD-L1) agent.
- Known history of hypersensitivity to macromolecular protein preparation or any components of the SHR-1210 formulation.
- Concurrent medical condition requiring the use of cortisol (>10mg/day Prednisone or equivalent dose) or other systematic immunosuppressive medications within 14 days before the study treament. Except: inhalation or topical corticosteroids. Doses > 10 mg/day prednisone or equivalen for replacement therapy.
- Has received prior anti-cancer monoclonal antibody (mAb), chemotherapy, targeted small molecule therapy, or radiation therapy within 4 weeks prior to study Day 1 or not recovered from adverse events due to a previously administered agent.
- Received a live vaccine within 4 weeks of the first dose of study medication.
- Pregnancy or breast feeding.
- Decision of unsuitableness by principal investigator or physician-in-charge.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study of Radiation Therapy With Anti-PD-1 Antibody SHR-1210 in Treating Patients With Unresectable Esophageal Cancer
The objective of this study is to evaluate the efficacy and safety of radiation therapy combined with anti-PD-1 antibody SHR-1210 in patients with esophageal cancer
- Being tested
- Radiation, SHR-1210
- Keywords
- Esophageal Squamous Cell Carcinoma, Radiation, Anti-PD-1 Antibody
- Medical subject headings
- Esophageal Neoplasms, Esophageal Diseases, Esophageal Squamous Cell Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiationDrug
RT to 60 Gy, 5 x per week，for 6 weeks. Radiation begun the day after the first dose of SHR-1210
SHR-1210Drug
SHR-1210 (200mg fixed dose every 2 weeks for 5 cycles) will be administered as an intravenous infusion over 60 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Radiation to 60 Gy, 5 x per week, for 6 weeks. Radiation begun the day after the first dose of SHR-1210. SHR-1210 (200mg fixed dose every 2 weeks for 5 cycles) will be administered as an intravenous infusion over 60 minutes. Receives: Drug: Radiation; Drug: SHR-1210 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
ORR was evaluated 4-8 weeks after completion of RT and was recorded according to RECIST, version 1.1.
Measured: 4-8 weeks
Secondary outcomes (5)
Treatment-emergent adverse events
Incidence of treatment-emergent adverse events would be assessed based on the common toxicity criteria for adverse events version 4.0 (CTCAE v4.0) and EORTC criterion.
Measured: year 0 - year 1
Local-regional free survival (LRFS)
LRFS was calculated from the date of treatment initiation to the date of documented failure.
Measured: year 0 - year 3
Overall survival
OS was determined as the time (in months) between the first day of therapy and the last follow-up or the date of death.
Measured: year 0 - year 3
Health-related quality of life (HRQoL)
HRQoL measured by standardized EORTC questionaires (EORTC QLQ-C30)
Measured: From baseline to one year after RT.
Health-related quality of life (HRQoL)
HRQoL measured by standardized EORTC questionaires (EORTC QLQ-OES18)
Measured: From baseline to one year after RT.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2017
- Study start14 Jun 2017
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal NeoplasmsStudies of the same condition, open and under way.
- 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
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hangzhou Cancer Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Responsible party
- Principal investigator, Shixiu Wu, Hangzhou Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03187314
- Sponsor's protocol ID
- HangzhouCH08
- Status last verified
- Aug 2020
- First submitted
- 13 Jun 2017
- Last updated
- 17 Aug 2020
- 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 17 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Radiation Therapy With Anti-PD-1 Antibody SHR-1210 in Treating Patients With Unresectable Esophageal Cancer
- ClinicalTrials.gov ID
- NCT03187314
- Acronym / sponsor ID
- HangzhouCH08
- Keywords
- Esophageal Squamous Cell Carcinoma, Radiation, Anti-PD-1 Antibody
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Hangzhou Cancer HospitalUniversity, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Study start
- 14 Jun 2017 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 14 Jun 2017 (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 objective of this study is to evaluate the efficacy and safety of radiation therapy combined with anti-PD-1 antibody SHR-1210 in patients with esophageal cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Drug: Radiation, Drug: SHR-1210Radiation to 60 Gy, 5 x per week, for 6 weeks. Radiation begun the day after the first dose of SHR-1210. SHR-1210 (200mg fixed dose every 2 weeks for 5 cycles) will be administered as an intravenous infusion over 60 minutes. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- age:18-75 years, male or femal.
- Histologically or cytologically confirmed Squamous Cell Carcinoma of the Esophagus, locally advanced, unresectable disease.
- Measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
- Can provide either a newly obtained or archival tumor tissue sample.
- ECOG 0-1.
Key exclusion criteria (16 listed)
- Patients who have or are currently undergoing additional chemotherapy, radiation therapy, targeted therapy or immunotherapy.
- Complete obstruction of the esophagus, or patients who have the potential to develop perforation
- Other malignancy within 5 years prior to entry into the study, expect for curatively treated basal cell and squamous cell carcinoma of the skin and/or curatively resected in-situ cervical and/or breast cancers.
- Known central nervous system (CNS) metastases.
- Subjects with any active autoimmune disease or history of autoimmune disease.
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 |
|---|---|---|
| RadiationRT to 60 Gy, 5 x per week，for 6 weeks. Radiation begun the day after the first dose of SHR-1210 | Drug | Experimental Group |
| SHR-1210SHR-1210 (200mg fixed dose every 2 weeks for 5 cycles) will be administered as an intravenous infusion over 60 minutes. | Drug | Experimental Group |
Primary outcome
Objective response rate (ORR)
Time frame: 4-8 weeks
ORR was evaluated 4-8 weeks after completion of RT and was recorded according to RECIST, version 1.1.
5 secondary outcomes
Treatment-emergent adverse events
Time frame: year 0 - year 1
Local-regional free survival (LRFS)
Time frame: year 0 - year 3
Overall survival
Time frame: year 0 - year 3
Health-related quality of life (HRQoL)
Time frame: From baseline to one year after RT.
Health-related quality of life (HRQoL)
Time frame: From baseline to one year after RT.
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 17 Aug 2020.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Radiation and SHR-1210 in people with Esophageal Neoplasms and Esophageal Diseases, run by Hangzhou Cancer 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 16 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 17 Aug 2020. 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?
Objective response rate (ORR) (time frame: 4-8 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 17 Aug 2020.