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This study is a prospective, open-label, single-arm, single-center clinical study, aiming to evaluate the efficacy and safety of sintilimab combined with platinum-based chemotherapy + pegylated recombinant human granulocyte stimulating factor as neoadjuvant treatment for resectable esophageal squamous cell carcinoma patients. In the study, all patients who meet the inclusion criteria will receive sintilimab combined with platinum-based chemotherapy for 2 cycles (21 days as one cycle) as neoadjuvant treatment according to the study plan. Pegylated recombinant human granulocyte stimulating factor will be given 24 hours after the end of chemotherapy, and radical surgical treatment will be received within 3-6 weeks after the completion of the last neoadjuvant treatment. Whether the subjects need adjuvant treatment after surgery and the adjuvant treatment plan will be determined by the investigators. All subjects need to complete the follow-up plan formulated by the study after surgery.
The patients selected for the study were those who were diagnosed with esophageal cancer for the first time. The recruited subjects should be:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neoadjuvant patients | Experimental | All subjects who meet the inclusion criteria will receive sintilimab combined with platinum-containing chemotherapy for 2 cycles (21 days for one cycle) as neoadjuvant therapy according to the research plan. Polyethylene glycolylated recombinant human granulocyte stimulating factor will be given 24 hours after the end of chemotherapy. Radical surgical treatment will be received within 3 to 6 weeks after the completion of the last neoadjuvant treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEG-rhG-GSF | Drug | Polyethylene glycolylated recombinant human granulocyte stimulating factor (6mg)will be given 24 hours after the end of chemotherapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| pCR | The pathological complete response rate (pCR) after neoadjuvant therapy | Radical surgical treatment will be received within 3 to 6 weeks after the completion of the last neoadjuvant treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| MPR | major pathological response, MPR | Radical surgical treatment will be received within 3 to 6 weeks after the completion of the last neoadjuvant treatment. |
| RFS | Recurrence Free Survival |
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Inclusion Criteria:
Voluntary signing of informed consent;
Male or female, aged 18 years or above and 75 years or below;
Patients diagnosed with esophageal squamous cell carcinoma by biopsy histopathological examination of the primary lesion; cervical metastasis was excluded by cervical B-ultrasound.
Patients who were judged by imaging and endoscopic ultrasound examination to have potentially surgically resectable middle and lower esophagus (below 18 cm from the incisors) and require neoadjuvant therapy (T2-4aNxM0, stage II-IVA); for T2N0M0, the length of the primary tumor under endoscopic examination was required to be ≥ 2 cm, located below the neck, and ≥ 5 cm away from the cricopharyngeal muscle.
Patients have not received any anti-tumor treatment in the past, including but not limited to surgery, radiotherapy, chemotherapy, immunotherapy, targeted therapy, etc.;
The ECOG performance status score is 0-1;
Have adequate heart, lung, liver and kidney functions, and the laboratory tests within 14 days before screening meet the following indicators:
i. Hemoglobin HB ≥ 90 g/L ii. Absolute neutrophil count ANC ≥ 1.5 × 109 /L iii. Platelet count PLT ≥ 80 × 109 /L iv. Albumin ALB ≥ 35 g/L v. Alanine aminotransferase ALT and aspartate aminotransferase AST ≤ 1.5 times the upper limit of the normal range vi. Total bilirubin ≤ 30 μmol/L vii. Creatinine SCr ≤ the upper limit of the normal range. viii. Coagulation: PT-INR ≤ 2.3 or PT < 6 seconds compared with the normal control
Patients need to be able to complete the treatment and follow-up according to the research plan on schedule;
Patients need to have sufficient tissue samples and agree to use their tissue samples and blood samples for research analysis;
Pregnancy tests in women of childbearing age were negative and were willing to take effective contraceptive measures during the study.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yanhong Gu, Ph.D. | Contact | 13813908678 | 025-68307881 | guluer@163.com |
| Ting Wang, Ph.D. | Contact | 18851196345 | 025-68307103 | wangting905@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yanhong Gu, Ph.D. | The First Affiliated Hospital with Nanjing Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the First Affiliated Hospital of Nanjing Medical University | Recruiting | Nanjing | Jiangsu | 210029 | China |
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| ID | Term |
|---|---|
| D000077277 | Esophageal Squamous Cell Carcinoma |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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All subjects who meet the inclusion criteria will receive sintilimab combined with platinum-containing chemotherapy for 2 cycles (21 days for 1 cycle) as neoadjuvant therapy according to the research plan. Polyethylene glycolylated recombinant human granulocyte stimulating factor will be given 24 hours after the end of chemotherapy. Radical surgical treatment will be received within 3-6 weeks after the completion of the last neoadjuvant treatment.
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|
| 5 years |
| R0 resection rate | The R0 resection rate after neoadjuvant therapy and subsequent surgery | Radical surgical treatment will be received within 3 to 6 weeks after the completion of the last neoadjuvant treatment. |
| AEs | New adjuvant therapy-related AEs | 4 years |
| D009369 | Neoplasms |
| D018307 | Neoplasms, Squamous Cell |
| D004938 | Esophageal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |