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China is a country with a large incidence of esophageal cancer. The prevalence and mortality rate of esophageal cancer in China ranks fifth in the world. However, due to China's huge population base, new patients with esophageal cancer and deaths account for about 55% of the world. This study aimed to explore the efficacy and safety of Camrelizumab Combined With Concurrent Radiotherapy and Chemotherapy for Treatment of Patients With Local Recurrence of Esophageal Cancer.
This is an open clinical study to evaluate the efficacy and safety of Camrelizumab combined with Concurrent Radiotherapy and Chemotherapy in the treatment of locally recurrent esophageal cancer.
Objective to study patients with local recurrence of esophageal cancer after radical treatment.
The study will take progression free survival (PFS) as the main efficacy index, and plan to enroll about 62 patients with local recurrence of esophageal cancer after radical treatment. After fully informed and signed the informed consent, the subjects will enter the experimental stage after screening.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Camrelizumab Combined With Concurrent Radiotherapy and Chemotherapy | Experimental | Camrelizumab (200mg Q2W, continuous medication until disease progression, intolerable toxicity, or withdrawal due to other reasons) Simultaneous radiotherapy (50-50.4Gy / 1.8-2Gy / 25-28F) Chemotherapy (Capecitabine, 625mg/m2, bid, oral, d1-5, qw, total 5 weeks). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Camrelizumab | Drug | Camrelizumab combined with concurrent radiotherapy and chemotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival,PFS | Time from randomization to patient's tumor progression or death | 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival,OS | The time from the beginning of randomization to death due to any cause. | 1 year |
| Objective Response Rate, ORR | The proportion of patients whose tumor shrinks to a certain amount and remains for a certain period of time |
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Inclusion Criteria:
(1) Blood routine examination:
a. HB≥90g / L; b.ANC≥1.5 × 109 / L; c.PLT≥80 × 109 / L; (2) Biochemical inspection:
a. ALB ≥ 30g / L; b. ALT and AST ≤ 2.5ULN; if there is liver metastasis, ALT and AST ≤ 5ULN; c. TBIL ≤ 1.5ULN; 7. 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; 8. Subjects voluntarily joined the study, signed an informed consent form, had good compliance, and cooperated with follow-up.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ruinuo Jia | Contact | 18537950766 | jiaruinuo@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Henan University of Science and Technology | Recruiting | Luoyang | Henan | 470000 | China |
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| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000631724 | camrelizumab |
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
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| 1 year |
| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |