Esophageal Malignant Neoplasm, Local Recurrence Clinical Trial
Official title:
The Third Phase of Immunotherapy and Concurrent Chemoradiotherapy in Patients With Esophageal Cancer Recurrence Was Compared With the Clinical Comparison
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.
| Status | Not yet recruiting |
| Enrollment | 240 |
| Est. completion date | June 30, 2023 |
| Est. primary completion date | December 30, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility |
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: 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, 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); 5. 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. |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| The First Affiliated Hospital of Henan University of Science and Technology |
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| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Grade 3/4 acute toxicities | rade 3/4 acute toxicities occurred during or within 90 days after CRT | 90 days | |
| Primary | PFS | Progression Free Survival After completion of the CRT | 1 year | |
| Secondary | ORR | overall remission rate | 16 weeks | |
| Secondary | OS Qol | overall survival | 1 year |