Clinical Control Study of Immunotherapy and Concurrent Chemoradiotherapy in Patients With Esophageal Cancer Recurrence

Study Overview
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Brief Summary
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Esophageal cancer is still a serious threat to human life and health. China in particular. Relapse and metastasis are important causes of treatment failure. Immunotherapy is a new treatment method, which can be used in combination with chemotherapy to improve the therapeutic effect. However, the role of immunotherapy combined with chemoradiotherapy in concurrent chemoradiotherapy of recurrent esophageal cancer has not been clearly studied. Our team will study it in detail. The purpose of this study was to compare and analyze the effect of Camrelizumab in concurrent chemoradiotherapy of locally recurrent esophageal cancer.

Detailed Description
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In this study, patients with local recurrence of esophageal carcinoma without distant metastasis were randomly divided into experimental group and control group by Block randomization. In the experimental group, patients with local recurrence were treated with Camrelizumab combined with concurrent chemoradiotherapy. Followed up for 3 years to observe the objective remission rate and disease-free survival. In the control group, patients with local recurrence were treated with placebo combined with concurrent chemoradiotherapy. Followed up for 3 years to observe the objective remission rate and disease-free survival.

Official Title
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The Third Phase of Immunotherapy and Concurrent Chemoradiotherapy in Patients With Esophageal Cancer Recurrence Was Compared With the Clinical Comparison

Conditions
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Esophageal Malignant Neoplasm, Local Recurrence

Intervention / Treatment
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* Drug: Procedural death 1
* Drug: Capecitabine
* Radiation: Radiotherapy
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1.Age 18-75 years old, both men and women; 2. Histologically confirmed as esophageal squamous cell carcinoma; 3. Postoperative local recurrence of esophageal cancer (stage II-IVA); 4. According to the evaluation criteria of RECIST 1.1, at least one measurable lesion; 5. ECOG: 0 ～ 1; 6. Expected survival time ≥ 12 weeks; 7. The function of main organs is normal, that is, it meets the following standards: Blood routine examination:a. HB≥90g / L; b.ANC≥1.5 × 109 / L; c.PLT≥80 × 109 / L;3.Biochemical inspection:a.ALB ≥ 30g / L; b. ALT and AST ≤ 2.5ULN; c. TBIL ≤ 1.5ULN; 8. Women of childbearing age should agree to use contraceptive measures (such as intrauterine devices, contraceptives or condoms) during the study period and within 6 months after the end of the study; the serum or urine pregnancy test is negative within 7 days before the study enrollment , and must be a non-lactating patient; males should agree to patients who must use contraception during the study period and within 6 months after the end of the study period; 9. Subjects voluntarily joined the study, signed an informed consent form, had good compliance, and cooperated with follow-up. Exclusion Criteria: Does not meet the above selection criteria; Patients with distant metastases; Those who are allergic to or metabolic disorders of capecitabine and Camrelizumab; The patient has any active autoimmune disease or has 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; The patient has vitiligo; Asthma has been completely relieved in childhood and can be included without any intervention after adulthood; Patients with asthma requiring medical intervention with bronchodilators cannot be included); The patient is using immunosuppressive agents or systemic hormone therapy to achieve the purpose of immunosuppression (dose> 10mg / day prednisone or other therapeutic hormones), and is still using it within 2 weeks before enrollment; 6. Contraindications to radiotherapy; 7. Severe infections that are active or uncontrolled; 8. Liver diseases such as decompensated liver disease, active hepatitis B (HBV-DNA≥104 copies / ml or 2000IU / ml) or hepatitis C (hepatitis C antibody is positive, and HCV-RNA is higher than the analytical method; 9. Patients whose imaging has shown that the tumor has invaded the important blood vessels or the investigator judges that the tumor is likely to invade the important blood vessels and cause fatal hemorrhage during the follow-up study; 10. Pregnant or lactating women; 11. Patients with other malignant tumors within 5 years (except basal cell carcinoma of the skin and cervical carcinoma in situ); 12. Patients with a history of psychotropic substance abuse who are unable to quit or have mental disorders; 13. Patients who have participated in clinical trials of other drugs within four weeks; 14. According to the judgment of the investigator, there are patients with concomitant diseases that seriously endanger the safety of the patient or affect the completion of the study; 15. The investigator considers it unsuitable for inclusion.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PD-1 and Concurrent chemoradiotherapy<br>Camrelizumab: 200mg,d1,15,29,43,57,I.V oxaliplatin：65mg/m2，d1，8，22, 29 capecitabine: 625mg/m2, bid d1-5; q1w, po,6 weeks in total. radiotherapy： 50-50.4Gy ，1.8-2 Gy/d，5d/w. | Drug: Procedural death 1<br>* 200mg,d1,15,29,43,57,I.V<br>* Other names: Camrelizumab;Drug: Capecitabine<br>* Capecitabine: 625mg/m2, bid d1-5; q1w, po,6 weeks in total.<br>* Other names: Aibin;Radiation: Radiotherapy<br>* radiotherapy： 50-50.4Gy ，1.8-2 Gy/d，5d/w.<br>* Other names: Radiation Therapy;|
| Placebo Comparator: placebo and Concurrent chemoradiotherapy<br>placebo: 200mg,d1,15,29,43,57,I.V oxaliplatin：65mg/m2，d1，8，22, 29 capecitabine: 625mg/m2, bid d1-5; q1w, po,6 weeks in total. radiotherapy： 50-50.4Gy ，1.8-2 Gy/d，5d/w. | Drug: Capecitabine<br>* Capecitabine: 625mg/m2, bid d1-5; q1w, po,6 weeks in total.<br>* Other names: Aibin;Radiation: Radiotherapy<br>* radiotherapy： 50-50.4Gy ，1.8-2 Gy/d，5d/w.<br>* Other names: Radiation Therapy;Drug: Placebo<br>* placebo: 200mg,d1,15,29,43,57,I.V<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Grade 3/4 acute toxicities | rade 3/4 acute toxicities occurred during or within 90 days after CRT | 90 days | 
| PFS | Progression Free Survival After completion of the CRT | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ORR | overall remission rate | 16 weeks | 
| OS Qol | overall survival | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Carrillizumab, Esophageal cancer recurred, concurrent radiochemotherapy