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Resectable Esophageal Squamous Cell CarcinomaPhase 2NCT04533490

A Phase Ⅱ Clinical Trial of Camrelizumab for Adjuvant Treatment of Resectable Esophageal Squamous Cell Carcinoma

A Phase 2 study testing SHR-1210 in people with Resectable Esophageal Squamous Cell Carcinoma, run by The First Affiliated Hospital of Zhengzhou University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to observe and evaluate the efficacy and safety of SHR-1210 for adjuvant treatment of resectable esophageal squamous cell carcinoma Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
SHR-1210
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
No sites listed yet
Study dates
1 Oct 2021to 1 Oct 2023
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

  • Histology confirmed as esophageal squamous cell carcinoma;
  • The clinical stages are cT1b-T4aN0M0, cT1-T4aN+M0;
  • The subjects were required to complete preoperative concurrent chemoradiotherapy and complete R0 resection before enrollment;
  • The shortest time of neoadjuvant therapy was 6 weeks and the longest was 12 weeks;
  • Postoperative pathology: T1 or above T1, N1 or N1 above, no distant metastasis;
  • Aged 18-75;
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  • ECOG:0-1;
  • 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;
  • 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;
  • There was no serious concomitant disease with a survival time of less than 5 years;
  • Voluntary and able to comply with the protocol during the study;
  • Provide written informed consent before entering the study, and patients have understood that they can withdraw from the study at any time without any loss.

Who cannot join

  • Patients with previous or concurrent malignant tumors, except for skin basal cell carcinoma and cervical carcinoma in situ that have been cured; patients with small gastric stromal tumor and other tumors, which are judged by researchers to have no impact on the patient's life in the short term, can be excluded;
  • Participated in other drug clinical trials within four weeks;
  • 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;
  • Any active malignant tumor within 2 years, except for the specific cancer under study in this study and locally recurrent cancer that has been cured (such as resected basal cell or squamous cell skin cancer, superficial bladder cancer, cervical or breast cancer in situ);
  • Patients with known history of CNS metastasis or CNS metastasis before screening. For patients with clinically suspected CNS metastasis, CT or MRI must be performed within 28 days before randomization to exclude CNS metastasis;
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  • Patients with unstable angina pectoris history, newly diagnosed angina pectoris within 3 months before screening or myocardial infarction events occurred within 6 months before screening; arrhythmias (including QTCF: male ≥ 450 ms, female ≥ 470 MS) need long-term use of antiarrhythmic drugs and NYHA grade ≥ II cardiac insufficiency;
  • Urine routine examination showed that urinary protein was ≥ + +, and 24-hour urinary protein was more than 1.0 G;
  • For female subjects: they should be surgical sterilization, postmenopausal patients, or agree to use a medically approved contraceptive method during the study treatment period and within 6 months after the end of the study treatment period; the serum or urine pregnancy test must be negative within 7 days before the study enrollment, and must be non lactation period. Male subjects: they should be surgical sterilization or agree to use a medically approved contraceptive method during the study treatment period and within 6 months after the end of the study treatment period;
  • The patient had received liver transplantation;
  • Patients with infectious pneumonia, non infectious pneumonia, interstitial pneumonia and other patients who need to use corticosteroids;
  • Have a history of chronic autoimmune diseases, such as systemic lupus erythematosus, etc;
  • Patients had a history of inflammatory bowel disease such as ulcerative enteritis and Crohn's disease, and a history of chronic diarrhea such as irritable bowel syndrome;
  • Patients with a history of sarcoidosis or tuberculosis;
  • Patients with a history of active hepatitis B and hepatitis C and HIV infected patients;
  • Patients with a history of psychotropic substance abuse and can't quit or have mental disorders;
  • Pleural effusion or ascites with clinical symptoms and requiring clinical intervention;
  • Patients with a history of immunodeficiency, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation;
  • According to the judgment of the researchers, there are accompanying diseases that seriously endanger the safety of patients or affect patients to complete the study.

Trial locations and contacts

No sites are listed yet.

Feng Wang contact

13938244776

fengw010@163.com

About this study

Official title: A Multi-center, Single-arm, Open Phase Ⅱ Clinical Trial of Camrelizumab for Adjuvant Treatment of Resectable Esophageal Squamous Cell Carcinoma

The purpose of this study is to observe and evaluate the efficacy and safety of SHR-1210 for adjuvant treatment of resectable esophageal squamous cell carcinoma

Read the detailed description

Although esophagectomy is still the standard treatment for patients with localized esophageal cancer, the long-term therapeutic effect is not satisfactory.About 50% of patients experienced relapse in the first year after treatment. The 5-year survival rate of esophageal cancer patients treated by surgery is still less than 30%. Although the effect of preoperative treatment is relatively clear, the effect of postoperative treatment, especially postoperative chemotherapy, is still controversial and no consensus has been reached.The basic reason is that the postoperative trauma of esophageal cancer is large, and the patients' tolerance to chemotherapy is poor. The efficacy of immunocheckpoint inhibitors in metastatic ESCC has been recognized.We plan to conduct a phase II multicenter, single arm, open phase II clinical trial to evaluate the efficacy and safety of humanized anti PD-1 monoclonal antibody SHR-1210 in adjuvant treatment of resectable esophageal squamous cell carcinoma.

Being tested
SHR-1210
Keywords
ESCC,Adjuvant therapy,Camrelizumab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SHR-1210Drug

    After the subjects were enrolled in the study, the patients were treated with SHR-1210 200mg igvtt q3w from 1 to 2 months after operation until disease progression or intolerable toxicity, and the longest medication period was no more than 12 months

Study groups in NCT04533490
Study groupRoleWhat they receive
SHR-1210ExperimentalAfter the subjects were enrolled in the study, the patients were treated with SHR-1210 (200mg ivgtt q3w) from 1 to 2 months after operation until disease progression or intolerable toxicity, and the longest medication period was no more than 12 months
Receives: Drug: SHR-1210

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. RFS(relapse free survival)

    Recurrence free survival of resectable esophageal squamous cell carcinoma treated with SHR-1210

    Measured: up to 1 year

  2. DFS（disease-free survival）

    Disease-free survival of resectable esophageal squamous cell carcinoma treated with SHR-1210

    Measured: up to 1 year

Secondary outcomes (1)

  1. OS（overall survival rate）

    From date of randomization until the date of death from any cause; Overall survival rate of resectable esophageal squamous cell carcinoma treated with SHR-1210

    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.

  1. First posted31 Aug 2020
  2. Study start1 Oct 2021 (estimated)
  3. Primary completion1 Oct 2022 (estimated)
  4. Study completion1 Oct 2023 (estimated)

Resources

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
42 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04533490
Sponsor's protocol ID
SHR-1210-123
Status last verified
Aug 2021
First submitted
21 Aug 2020
Last updated
23 Aug 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SHR-1210 in people with Resectable Esophageal Squamous Cell Carcinoma, run by The First Affiliated Hospital of Zhengzhou University.

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 15 inclusion and 19 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 23 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

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?

RFS(relapse free survival) (time frame: up to 1 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?

On the ClinicalTrials.gov record for NCT04533490.

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 23 Aug 2021.

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