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

Last updated: May 21, 2020
Sponsor: The First Affiliated Hospital of Henan University of Science and Technology
Overall Status: Active - Not Recruiting

Phase

3

Condition

Esophageal Disorders

Digestive System Neoplasms

Neoplasms

Treatment

N/A

Clinical Study ID

NCT04404491
ITCRTECR
  • Ages 18-75
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

1.Age 18-75 years old, both men and women; 2. Histologically confirmed as esophagealsquamous cell carcinoma; 3. Postoperative local recurrence of esophageal cancer (stageII-IVA); 4. According to the evaluation criteria of RECIST 1.1, at least one measurablelesion; 5. ECOG: 0 ~ 1; 6. Expected survival time ≥ 12 weeks; 7. The function of mainorgans 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 touse contraceptive measures (such as intrauterine devices, contraceptives or condoms) duringthe study period and within 6 months after the end of the study; the serum or urinepregnancy test is negative within 7 days before the study enrollment , and must be anon-lactating patient; males should agree to patients who must use contraception during thestudy period and within 6 months after the end of the study period; 9. Subjects voluntarilyjoined the study, signed an informed consent form, had good compliance, and cooperated withfollow-up.

Exclusion

Exclusion Criteria:

  1. Does not meet the above selection criteria;

  2. Patients with distant metastases;

  3. Those who are allergic to or metabolic disorders of capecitabine and Camrelizumab;

  4. The patient has any active autoimmune disease or has a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitialpneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis,nephritis , Hyperthyroidism; The patient has vitiligo; Asthma has been completelyrelieved in childhood and can be included without any intervention after adulthood;Patients with asthma requiring medical intervention with bronchodilators cannot beincluded);

  5. The patient is using immunosuppressive agents or systemic hormone therapy to achievethe purpose of immunosuppression (dose> 10mg / day prednisone or other therapeutichormones), and is still using it within 2 weeks before enrollment; 6.Contraindications to radiotherapy;

  6. Severe infections that are active or uncontrolled; 8. Liver diseases such asdecompensated liver disease, active hepatitis B (HBV-DNA≥104 copies / ml or 2000IU / ml) orhepatitis C (hepatitis C antibody is positive, and HCV-RNA is higher than the analyticalmethod; 9. Patients whose imaging has shown that the tumor has invaded the important bloodvessels or the investigator judges that the tumor is likely to invade the important bloodvessels and cause fatal hemorrhage during the follow-up study; 10. Pregnant or lactatingwomen; 11. Patients with other malignant tumors within 5 years (except basal cell carcinomaof the skin and cervical carcinoma in situ); 12. Patients with a history of psychotropicsubstance abuse who are unable to quit or have mental disorders; 13. Patients who haveparticipated in clinical trials of other drugs within four weeks; 14. According to thejudgment of the investigator, there are patients with concomitant diseases that seriouslyendanger the safety of the patient or affect the completion of the study; 15. Theinvestigator considers it unsuitable for inclusion.

Study Design

Total Participants: 240
Study Start date:
June 01, 2020
Estimated Completion Date:
June 30, 2023

Study Description

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.