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The purpose of this study was to evaluate the effect and safety of concurrent PD-1 antibody-based long-term radiotherapy followed by 2 cycles SOX with PD-1 in patients with locally advanced adenocarcinoma of esophagogastric junction.
The incidence of adenocarcinoma of the esophagogastric junction (AEG) is increasing in Asian countries and Western Contries. Surgical resection is the most important treatment for AEG. However, the recurrence rate is high when surgery is performed alone. The results of CLASSIC, MAGIC, FLOT4, JCOG0501, PRODIGY, RESOLVE, CROSS trial showed that perioperative chemotherapy and pre- or postoperative chemoradiotherapy significantly increase the overall survival rate and disease free survival rate compared to surgery alone. Radiotherapy and immunotherapy can increase sensitivity to each other, and several clinical studies have also showed that PD-1 antibody may significantly prolongs the life.Thus the investigators plan to conduct this clinical trial to evaluate the effect and safety of concurrent PD-1 antibody-based long-term radiotherapy followed by 2 cycles SOX with PD-1 in patients with locally advanced adenocarcinoma of esophagogastric junction.
Subjects will receive long-term radiotherapy (5w) concurrent with PD-1 antibody for 2 cycles, then receive two cycles of SOX regimen combined PD-1 after a week's rest. Surgery will be performed 2 weeks after the last cycle of neoadjuvant treatment. Adjuvant treatment will be started 3 to 8 weeks after surgery, and SOX regimen will be given for 4 cycles.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neoadjuvant therpy | Experimental | Neoadjuvant chemoradiation plus SOX and PD-1 antibody |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| neoadjuvant Radiation plus SOX and PD-1 antibody | Drug | Patients will be given the perioperative treatment as below once recruited: First, neoradiation (5w) will be given: intensity modulated radiotherapy was given for tumors and high-risk lymphatic drainage areas. PD-1 antibody will be started concurrent the radiation for 2 cycles. The neochemotherapy (SOX) and PD-1 antibody will be given for 2 cycles after 1 week since radiation completed ; Patients will rest 2 weeks after the last cycle of neochemotherapy, and evaluation will be performed during this time. And D2 surgery will be performed if resectable. SOX and PD-1 antibody will be given q3w. Adjuvant chemotherapy: We advise starting 4 cycles of SOX regimen in 3-8w after surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Pathological Complete Responce (pCR) Rate | Proportion of patients with AEG who received neoadjuvant theray with radiation plus PD-1 antibody and SOX regimen and postoperative pathological examination shows pathological complete responce | Up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| R0 Resection Rate | Proportion of patients with AEG who received surgery with pathological pathological examination proved microscopically margin-negative resection | Up to 6 months |
| Progression Free Survival (PFS) |
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Inclusion Criteria:
Exclusion Criteria:
13. Allergic to any drug in this study. 14. Combined with other severe, acute and chronic diseases that may increase the risk of participating.
15.Participators who had been recruited by other clinical trial within three months.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liyu Zhu, MD | Contact | +8610-66583821 | wcwkzlward@163.com | |
| Jing Zhou, MD | Contact | +8610-66583820 | wcwkzlward@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yingjiang Ye, MD,PhD | Peking University People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Beijing | Beijing Municipality | 100044 | China |
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Disease Free Survival was defined as the time from the date of surgery to the date of the local recurrence, and/or distant disease, or tumor-related death.
| Up to 3 years |
| Adverse Events | For any adverse reactions, the researchers refer to the National Cancer Institute (NCI) standard of common toxicity (CTC) | Up to 6 months |
| Surgery Morbidity | Surgical morbidity reported according to Clavien-Dindo classification | 30 days and 12-months after surgery |
| ID | Term |
|---|---|
| C565324 | Parkinson Disease 4, Autosomal Dominant Lewy Body |
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| ID | Term |
|---|---|
| D020360 | Neoadjuvant Therapy |
| D007167 | Immunotherapy |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D056747 | Immunomodulation |
| D001691 | Biological Therapy |
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