Esophageal Squamous Cell CarcinomaPhase 2NCT03817658
A Phase II Study of SHR-1210 vs Placebo as Consolidation Chemotherapy After Radical Concurrent Chemoradiotherapy in Locally Advanced ESCC
A Phase 2 study testing SHR-1210 in people with Esophageal Squamous Cell Carcinoma, run by The First Affiliated Hospital of Zhengzhou University at 1 site in China.
Trial summary
The purpose of this study is to observe and evaluate the efficacy and safety of SHR-1210 vs placebo as consolidation chemotherapy after radical concurrent chemoradiotherapy for unresectable locally advanced ESCC. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma
- What is being tested?
- SHR-1210
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 725 participants
- Where
- 1 siteChina
- Study dates
- Oct 2019to Oct 2021
- 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 old, both men and women;
- Histology confirmed as esophageal squamous cell carcinoma;
- T1bN+M0, T2N0-2M0 local progress period;
- According to RECIST 1.1, at least one measurable lesion;
- Tissue samples shall be provided for biomarker analysis, preferably newly acquired tissues, and patients who are unable to provide newly acquired tissues may provide 5-8 pieces of 5um thick paraffin sections that are archived and preserved;
- ECOG: 0~1;
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- Expected survival period ≥ 12 weeks;
- The main organs function normally, that is, the following criteria are met:
- Blood routine examination:
- HB≥90g/L;
- ANC ≥ 1.5 × 109 / L;
- PLT ≥ 80 × 109 / L; (2) Biochemical examination:
- ALB ≥ 30g / L; b. ALT and AST ≤ 2.5ULN; if there is liver metastasis, ALT and AST ≤ 5ULN; c. TBIL ≤ 1.5ULN; d. plasma Cr ≤ 1.5ULN or creatinine clearance (CCr) ≥ 60ml / min; 9. Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) ≥ normal low limit (50%); 10. Women of childbearing age should agree to use contraceptives (such as intrauterine devices, contraceptives or condoms) during the study period and within 6 months after the end of the study; negative serum or urine pregnancy test within 7 days prior to study enrollment And must be non-lactating patients; males should agree to patients who must use contraception during the study period and within 6 months after the end of the study period; 11. Subjects voluntarily joined the study, signed informed consent, and were well-adhered to follow-up.
Who cannot join
- Does not meet the above inclusion criteria;
- Those who are allergic or metabolically dying of capecitabine and cisplatin;
- The patient has any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, Hyperthyroidism; patients with vitiligo; Asthma has been completely relieved in childhood, and patients who do not need any intervention after adulthood can be included; asthma patients who require bronchodilators for medical intervention cannot be included);
- The patient is using immunosuppressive agents or systemic hormonal therapy for immunosuppressive purposes (dose > 10 mg/day of prednisone or other therapeutic hormones) and continues to be used for 2 weeks prior to enrollment;
- Radiotherapy contraindications;
- Patients with any severe and/or uncontrolled diseases;
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- Patients with unsatisfactory blood pressure control (systolic blood pressure ≥150mmHg or diastolic blood pressure ≥100 mmHg); myocardial ischemia or myocardial infarction with grade I or above, arrhythmia (including QT interval ≥480ms) and grade I cardiac insufficiency;
- Active or uncontrolled serious infections;
- Liver diseases such as decompensated liver disease, active hepatitis B (HBV-DNA ≥ 104 copies/ml or 2000 IU/ml) or hepatitis C (positive hepatitis C antibody, and HCV-RNA is higher than the lower limit of detection of the analytical method);
- Urine routine indicates that urine protein ≥ ++, and confirmed 24-hour urine protein quantitation > 1.0g;
- Imaging shows that the tumor has invaded the important perivascular circumference or that the patient is likely to invade the important blood vessels and cause fatal bleeding during the follow-up study;
- Pregnant or lactating women;
- Patients with other malignancies within 5 years (except for basal cell carcinoma and cervical carcinoma in situ) that have been cured;
- Patients with a history of psychotropic substance abuse who are unable to quit or have a mental disorder;
- Patients who have participated in other drug clinical trials within four weeks;
- At the discretion of the investigator, there are patients with serious concomitant disease that compromises patient safety or affects the patient's completion of the study;
- The investigator believes that it is not suitable for inclusion.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
About this study
Official title: A Phase II Clinical Trial of Anti-PD-1 Antibody SHR-1210 Versus Placebo as Consolidation Chemotherapy After Radical Concurrent Chemoradiotherapy in Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma
The purpose of this study is to observe and evaluate the efficacy and safety of SHR-1210 vs placebo as consolidation chemotherapy after radical concurrent chemoradiotherapy for unresectable locally advanced ESCC.
Read the detailed description
In China, the incidence of esophageal cancer has declined in recent years, but the mortality rate has been ranked fourth. Morbidity and mortality were ranked sixth and fourth in all malignancies, respectively. Therefore, esophageal cancer has always been a major malignant tumor that threatens the health of our residents. We designed a multicenter, randomized, double-blind, open-label phase II clinical trial of anti-PD-1 antibody SHR-1210 versus placebo as consolidation chemotherapy (CCT) after radical concurrent chemoradiotherapy for unresectable locally advanced esophageal squamous cell carcinoma (ESCC).The purpose of this study is to observe and evaluate the efficacy and safety of SHR-1210 vs placebo as consolidation chemotherapy after radical concurrent chemoradiotherapy for unresectable locally advanced ESCC.
- Conditions
- Esophageal Squamous Cell Carcinoma
- Being tested
- SHR-1210, Placebo
- Medical subject headings
- Esophageal Squamous Cell Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-1210Drug
First stage：
Concurrent chemoradiotherapy:
Cisplatin：25-30mg/m2 ivgtt d1;Capecitabine：800mg/m2, bid d1-5，qw，5weeks；Synchronous radiotherapy：1.8-2Gy/d，5d/W，45-50Gy。 Consolidation treatment： Cisplatin： 60-75mg/m2 ivgtt d1 Capecitabine：1000mg/m2, bid d1-14，q3w 6weeks。
Second stage:
SHR-1210 was administered intravenously (no prophylactic use), a fixed dose of 200 mg, and 3 mg/kg for subjects with a baseline weight <50 kg. Each infusion for 30 min (not less than 20 min, no more than 60 min), once every 2 weeks, 1 cycle every 4 weeks, the cumulative longest medication period is 12 months.
PlaceboDrug
First stage：
Concurrent chemoradiotherapy:
Cisplatin：25-30mg/m2 ivgtt d1;Capecitabine：800mg/m2, bid d1-5，qw，5weeks；Synchronous radiotherapy：1.8-2Gy/d，5d/W，45-50Gy。 Consolidation treatment： Cisplatin： 60-75mg/m2 ivgtt d1 Capecitabine：1000mg/m2, bid d1-14，q3w 6weeks。
Second stage:
Placebo was administered intravenously (no prophylactic use), a fixed dose of 200 mg, and 3 mg/kg for subjects with a baseline weight <50 kg. Each infusion for 30 min (not less than 20 min, no more than 60 min), once every 2 weeks, 1 cycle every 4 weeks, the cumulative longest medication period is 12 months.
| Study group | Role | What they receive |
|---|---|---|
| SHR-1210 | Experimental | SHR-1210 Receives: Drug: SHR-1210 |
| placebo | Placebo comparator | placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Evaluation of anti-PD-1 antibody SHR-1210 for progression-free survival in patients with locally advanced esophageal squamous cell carcinoma who did not develop disease after concurrent chemoradiotherapy
Measured: up to 2 year
OS
From date of randomization until the date of death from any cause
Measured: up to 2 year
Secondary outcomes (6)
ORR
Evaluation of the objective response rate of anti-PD-1 antibody SHR-1210 versus placebo in patients with locally advanced esophageal squamous cell carcinoma who had no disease progression after concurrent chemoradiotherapy(RECIST 1.1)
Measured: up to 2 year
DOR
defined as the time from the first determination of an objective response until the first documentation of progression assessed by BIRC per RECIST v1.1 or death, whichever comes first
Measured: up to 2 year
Health-Related Quality of Life (HRQoL)
assessment of the patient's overall health status using European Quality of Life-Core 30 Questionnaire index (EORTC QLQ-C30).
Measured: up to 2 year
Health-Related Quality of Life (HRQoL)
assessment of the patient's overall health status using the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire esophageal cancer specific module (EORTC QLQ-OES18).
Measured: up to 2 year
Health-Related Quality of Life (HRQoL)
assessment of the patient's overall health status using the generic health state instrument European Quality of Life- 5 Dimensions (EuroQol 5D EQ-5D-5L).
Measured: up to 2 year
The incidence and severity of adverse events (AEs)
according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v4.03
Measured: up to 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2019
- Study startOct 2019 (estimated)
- Primary completionOct 2020 (estimated)
- Study completionOct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Zhengzhou 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 725 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Responsible party
- Principal investigator, Feng Wang, The First Affiliated Hospital of Zhengzhou University
- Investigators
- Feng Wang, Principal investigator, The First Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03817658
- Sponsor's protocol ID
- SHR-1210--01
- Status last verified
- Jan 2019
- First submitted
- 23 Jan 2019
- Last updated
- 25 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical Trial of Anti-PD-1 Antibody SHR-1210 Versus Placebo as Consolidation Chemotherapy After Radical Concurrent Chemoradiotherapy in Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT03817658
- Acronym / sponsor ID
- SHR-1210--01
- Conditions
- Esophageal Squamous Cell Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 725 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Zhengzhou UniversityUniversity, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Study start
- Oct 2019 (estimated)
- Primary completion
- Oct 2020 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 25 Jan 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.
The purpose of this study is to observe and evaluate the efficacy and safety of SHR-1210 vs placebo as consolidation chemotherapy after radical concurrent chemoradiotherapy for unresectable locally advanced ESCC.
Detailed description
In China, the incidence of esophageal cancer has declined in recent years, but the mortality rate has been ranked fourth. Morbidity and mortality were ranked sixth and fourth in all malignancies, respectively. Therefore, esophageal cancer has always been a major malignant tumor that threatens the health of our residents. We designed a multicenter, randomized, double-blind, open-label phase II clinical trial of anti-PD-1 antibody SHR-1210 versus placebo as consolidation chemotherapy (CCT) after radical concurrent chemoradiotherapy for unresectable locally advanced esophageal squamous cell carcinoma (ESCC).The purpose of this study is to observe and evaluate the efficacy and safety of SHR-1210 vs placebo as consolidation chemotherapy after radical concurrent chemoradiotherapy for unresectable locally advanced ESCC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SHR-1210 | Experimental | Drug: SHR-1210SHR-1210 |
| placebo | Placebo comparator | Drug: Placeboplacebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age 18-75 years old, both men and women;
- Histology confirmed as esophageal squamous cell carcinoma;
- T1bN+M0, T2N0-2M0 local progress period;
- According to RECIST 1.1, at least one measurable lesion;
- Tissue samples shall be provided for biomarker analysis, preferably newly acquired tissues, and patients who are unable to provide newly acquired tissues may provide 5-8 pieces of 5um thick paraffin sections that are archived and preserved;
Key exclusion criteria (17 listed)
- Does not meet the above inclusion criteria;
- Those who are allergic or metabolically dying of capecitabine and cisplatin;
- The patient has any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, Hyperthyroidism; patients with vitiligo; Asthma has been completely relieved in childhood, and patients who do not need any intervention after adulthood can be included; asthma patients who require bronchodilators for medical intervention cannot be included);
- The patient is using immunosuppressive agents or systemic hormonal therapy for immunosuppressive purposes (dose > 10 mg/day of prednisone or other therapeutic hormones) and continues to be used for 2 weeks prior to enrollment;
- Radiotherapy contraindications;
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-1210First stage： Concurrent chemoradiotherapy: Cisplatin：25-30mg/m2 ivgtt d1;Capecitabine：800mg/m2, bid d1-5，qw，5weeks；Synchronous radiotherapy：1.8-2Gy/d，5d/W，45-50Gy。 Consolidation treatment： Cisplatin： 60-75mg/m2 ivgtt d1 Capecitabine：1000mg/m2, bid d1-14，q3w 6weeks。 Second stage: SHR-1210 was administered intravenously (no prophylactic use), a fixed dose of 200 mg, and 3 mg/kg for subjects with a baseline weight <50 kg. Each infusion for 30 min (not less than 20 min, no more than 60 min), once every 2 weeks, 1 cycle every 4 weeks, the cumulative longest medication period is 12 months. | Drug | SHR-1210 |
| PlaceboFirst stage： Concurrent chemoradiotherapy: Cisplatin：25-30mg/m2 ivgtt d1;Capecitabine：800mg/m2, bid d1-5，qw，5weeks；Synchronous radiotherapy：1.8-2Gy/d，5d/W，45-50Gy。 Consolidation treatment： Cisplatin： 60-75mg/m2 ivgtt d1 Capecitabine：1000mg/m2, bid d1-14，q3w 6weeks。 Second stage: Placebo was administered intravenously (no prophylactic use), a fixed dose of 200 mg, and 3 mg/kg for subjects with a baseline weight <50 kg. Each infusion for 30 min (not less than 20 min, no more than 60 min), once every 2 weeks, 1 cycle every 4 weeks, the cumulative longest medication period is 12 months. | Drug | placebo |
Primary outcome
PFS
Time frame: up to 2 year
Evaluation of anti-PD-1 antibody SHR-1210 for progression-free survival in patients with locally advanced esophageal squamous cell carcinoma who did not develop disease after concurrent chemoradiotherapy
OS
Time frame: up to 2 year
From date of randomization until the date of death from any cause
6 secondary outcomes
ORR
Time frame: up to 2 year
DOR
Time frame: up to 2 year
Health-Related Quality of Life (HRQoL)
Time frame: up to 2 year
Health-Related Quality of Life (HRQoL)
Time frame: up to 2 year
Health-Related Quality of Life (HRQoL)
Time frame: up to 2 year
The incidence and severity of adverse events (AEs)
Time frame: up to 2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2019.
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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.
Feng Wang principal investigator
The First Affiliated Hospital of Zhengzhou University
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 in people with Esophageal Squamous Cell Carcinoma, run by The First Affiliated Hospital of Zhengzhou 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 13 inclusion and 17 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 25 Jan 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. Some participants in this study may receive a placebo. 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 Feng Wang (13938244776, fengw010@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: up to 2 year). 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 25 Jan 2019.