Locally Advanced Esophageal Squamous Cell CarcinomaPhase 2NCT03917966
The Phase II Trial of SHR-1210 Combined With Preoperative Chemotherapy or Apatinib for Locally Advanced ESCC
A Phase 2 study testing SHR-1210+docetaxel+nedaplatin and SHR-1210+Apatinib in people with Locally Advanced 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 combined with preoperative chemotherapy or Apatinib for locally advanced esophageal squamous cell carcinoma Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Locally Advanced Esophageal Squamous Cell Carcinoma
- What is being tested?
- SHR-1210+docetaxel+nedaplatin and SHR-1210+Apatinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 7 Apr 2020to 7 Oct 2024
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-80 years old, both men and women;
- Histology confirmed as esophageal squamous cell carcinoma;
- Resectable stage Ⅱ/Ⅲ/Ⅳa（cT2-4aN0-3M0）;
- ECOG: 0~1;
- Expected survival period≥12 weeks;
- The main organs function normally, that is, the following criteria are met:(1)Blood routine examination:a.HB≥90g/L; b.ANC≥1.5×109 / L; c.PLT≥80×109 / L (2)Biochemical examination:a.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;
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- Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) ≥ normal low limit (50%);
- 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;
- Subjects voluntarily joined the study, signed informed consent, and were well-adhered to follow-up;
- Can swallow tablets normally.
Who cannot join
- Does not meet the above inclusion criteria;
- Those who are allergic to or sensitive to Docetaxel and nedaplatin;
- 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;
- Patients with any severe and/or uncontrolled diseases: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;
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- 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;
- 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;
- Patients with esophageal squamous cell carcinoma whose primary focus is active bleeding;
- With active ulcer, unhealed wound or fracture;
- Suffer from hypertension and cannot be well controlled by antihypertensive drugs (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg);
- Abnormal coagulation function (INR > 2.0 or prothrombin time (PT) > 16S), bleeding tendency or undergoing thrombolytic or anticoagulant therapy (preventive use of low-dose aspirin and low molecular weight heparin is allowed);
- Patients with clinically significant bleeding symptoms or definite bleeding tendency within the first three months of randomization, such as gastrointestinal bleeding, hemorrhagic gastric ulcer or vasculitis, can be reexamined if the stool occult blood is positive in the baseline period. If it is still positive after reexamination, endoscopic examination is required (except those who have accepted endoscopic examination within three months before enrollment and excluded such cases);
- Arteriovenous thrombosis events occurred within the first 6 months of randomization, such as cerebrovascular accidents (including transient ischemic attack, intracerebral hemorrhage and cerebral infarction), deep venous thrombosis and pulmonary embolism;
- Known hereditary or acquired bleeding and thrombotic tendency (such as hemophilia, coagulation dysfunction, thrombocytopenia, etc.);
- Routine urine examination showed that urinary protein was ≥ + + and it was confirmed that the amount of urinary protein in 24 hours was > 1.0 g;
- Patients with supraclavicular lymph node metastasis; Poor nutritional status, BMI < 18.5 kg / m2; If it is corrected before randomization after symptomatic nutritional support, it can continue to be considered after evaluation by the main investigator
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
Feng Wang, doctor
About this study
Official title: The Phase II Trial of SHR-1210 Combined With Preoperative Chemotherapy or Apatinib for Locally Advanced Esophageal Squamous Cell Carcinoma
The purpose of this study is to observe and evaluate the efficacy and safety of SHR-1210 combined with preoperative chemotherapy or Apatinib for locally advanced esophageal squamous cell carcinoma
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. Investigator designed a single-arm, open-label, phase II trial of SHR-1210 combined with preoperative chemotherapy or Apatinib for locally advanced esophageal squamous cell carcinoma. The purpose of this study is to observe and evaluate the efficacy and safety of SHR-1210 combined with preoperative chemotherapy or Apatinib for locally advanced esophageal squamous cell carcinoma.
- Being tested
- SHR-1210+docetaxel+nedaplatin, SHR-1210+Apatinib
- Keywords
- locally advanced esophageal squamous cell carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-1210+docetaxel+nedaplatinDrug
neoadjuvant chemotherapy:SHR-1210, 200mg,q2w, a total of 3 times; docetaxel 75mg/m2 ivgtt d1, nedaplatin 75mg/m2 ivgtt d1, q3w, for 2 cycles.The patient was evaluated after 2 cycles of neoadjuvant chemotherapy. The surgery was performed 3-4 weeks after the completion of neoadjuvant chemotherapy.
SHR-1210+ApatinibDrug
SHR-1210, 200 mg, q2w; Apatinib, 250mg, qd; 4 weeks is a cycle, a total of 2 cycles
| Study group | Role | What they receive |
|---|---|---|
| SHR-1210+Docetaxel+nedaplatin | Experimental | SHR-1210+Docetaxel+nedaplatin Receives: Drug: SHR-1210+docetaxel+nedaplatin |
| SHR-1210+Apatinib | Experimental | SHR-1210+Apatinib Receives: Drug: SHR-1210+Apatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major pathological response（MPR）
defined as ≤ 10% residual viable tumor at the time of surgical resection, as assessed by central pathology laboratory.
Measured: At time of surgery
Secondary outcomes (5)
Pathological Complete Response (pCR)
defined as the absence of any viable tumor at the time of surgical resection, as assessed by central and local pathology laboratory
Measured: At time of surgery
Overall Survival (OS)
defined as the time from randomization to death from any cause during the course of the study.
Measured: up to 2 year
Disease-Free Survival (DFS)
Time after R0 resection to disease recurrence or death
Measured: up to 2 year
Lymph node derating rate
Lymph node derating rate
Measured: At time of surgery
R0 resection rate
R0 resection rate
Measured: At time of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2019
- Study start7 Apr 2020
- Primary completion7 Oct 2023 (estimated)
- Study completion7 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 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
- NCT03917966
- Sponsor's protocol ID
- SHR-1210-02
- Status last verified
- Aug 2021
- First submitted
- 14 Apr 2019
- Last updated
- 4 Mar 2022
- 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 4 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Phase II Trial of SHR-1210 Combined With Preoperative Chemotherapy or Apatinib for Locally Advanced Esophageal Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT03917966
- Acronym / sponsor ID
- SHR-1210-02
- Keywords
- locally advanced esophageal squamous cell carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Zhengzhou UniversityUniversity, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Study start
- 7 Apr 2020 (actual)
- Primary completion
- 7 Oct 2023 (estimated)
- Study completion
- 7 Oct 2024 (estimated)
- First posted
- 17 Apr 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 combined with preoperative chemotherapy or Apatinib for locally advanced esophageal squamous cell carcinoma
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. Investigator designed a single-arm, open-label, phase II trial of SHR-1210 combined with preoperative chemotherapy or Apatinib for locally advanced esophageal squamous cell carcinoma. The purpose of this study is to observe and evaluate the efficacy and safety of SHR-1210 combined with preoperative chemotherapy or Apatinib for locally advanced esophageal squamous cell carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SHR-1210+Docetaxel+nedaplatin | Experimental | Drug: SHR-1210+docetaxel+nedaplatinSHR-1210+Docetaxel+nedaplatin |
| SHR-1210+Apatinib | Experimental | Drug: SHR-1210+ApatinibSHR-1210+Apatinib |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age 18-80 years old, both men and women;
- Histology confirmed as esophageal squamous cell carcinoma;
- Resectable stage Ⅱ/Ⅲ/Ⅳa（cT2-4aN0-3M0）;
- ECOG: 0~1;
- Expected survival period≥12 weeks;
Key exclusion criteria (23 listed)
- Does not meet the above inclusion criteria;
- Those who are allergic to or sensitive to Docetaxel and nedaplatin;
- 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;
- Patients with any severe and/or uncontrolled diseases: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;
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+docetaxel+nedaplatinneoadjuvant chemotherapy:SHR-1210, 200mg,q2w, a total of 3 times; docetaxel 75mg/m2 ivgtt d1, nedaplatin 75mg/m2 ivgtt d1, q3w, for 2 cycles.The patient was evaluated after 2 cycles of neoadjuvant chemotherapy. The surgery was performed 3-4 weeks after the completion of neoadjuvant chemotherapy. | Drug | SHR-1210+Docetaxel+nedaplatin |
| SHR-1210+ApatinibSHR-1210, 200 mg, q2w; Apatinib, 250mg, qd; 4 weeks is a cycle, a total of 2 cycles | Drug | SHR-1210+Apatinib |
Primary outcome
Major pathological response（MPR）
Time frame: At time of surgery
defined as ≤ 10% residual viable tumor at the time of surgical resection, as assessed by central pathology laboratory.
5 secondary outcomes
Pathological Complete Response (pCR)
Time frame: At time of surgery
Overall Survival (OS)
Time frame: up to 2 year
Disease-Free Survival (DFS)
Time frame: up to 2 year
Lymph node derating rate
Time frame: At time of surgery
R0 resection rate
Time frame: At time of surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2022.
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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+docetaxel+nedaplatin and SHR-1210+Apatinib in people with Locally Advanced 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 10 inclusion and 23 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 4 Mar 2022. 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 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?
Major pathological response（MPR） (time frame: At time of surgery). 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 4 Mar 2022.