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| Name | Class |
|---|---|
| National Natural Science Foundation of China | OTHER_GOV |
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To purpose of this study is to access the safety and efficacy of neoadjuvant Immunotherapy (PD-1 / PD-L1) combined with chemotherapy for locally advanced thoracic esophageal squamous cellcarcinoma.
Each patient will complete 2 cycles of neoadjuvant therapy and decide whether to operate after evaluating the curative effect if there is no active withdrawal of the subject from the trial or the researcher believes that the subject is not suitable for further trials. The patients after operation and without operation enter the survival follow-up period. If the imaging evaluation is PD after neoadjuvant therapy, the follow-up treatment shall be carried out according to the following principles: the imaging evaluation belongs to the continuous operation that can be operated; If the imaging evaluation was inoperable, radical concurrent radiotherapy and chemotherapy were performed. Postoperative adjuvant therapy shall be performed according to NCCN guidelines. If it is necessary to improve the local control rate, postoperative adjuvant radiotherapy is feasible. At the same time, imaging evaluation was performed until tumor recurrence and metastasis. After tumor recurrence and metastasis, all patients should also enter survival follow-up; In case of drug withdrawal (such as intolerable toxicity) other than recurrence and metastasis during treatment, the treatment is completed, the post-treatment visit is entered, and the survival follow-up is entered after recurrence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neoadjuvant Immunotherapy (PD-1 / PD-L1) Combined With Chemotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neoadjuvant Immunotherapy (PD-1 / PD-L1) Combined With Chemotherapy | Procedure | Each patient will complete 2 cycles of neoadjuvant therapy. After evaluating the curative effect, decide whether to operate or not. Patients with and without surgery enter the survival follow-up period. |
| Measure | Description | Time Frame |
|---|---|---|
| Pathologic Complete Response | According to the detection of pathological specimens after operation, no malignant tumor cells were detected, so the patient achieved complete pathological remission. | 2-5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free Survival | The patient achieved CR (complete remission) and still had no probability of recurrence after treatment in 2-years. | 2-5 years |
| Progression-Free-Survival | The time between the beginning of treatment and the observation of disease progression or death from any cause. |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor markers | Tumor markers refer to those characteristic bioactive substances that can be detected that can reflect the development stage of malignant tumor cells. In a narrow sense, tumor markers refer to bioactive substances synthesized, secreted and released into blood and / or body fluid by malignant tumor cells, including enzymes, hormones, proteins, metabolites and other substances, Their occurrence and changes are closely related to the growth, diffusion, occurrence and development of malignant tumors. |
Inclusion Criteria:
Exclusion Criteria:
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In this clinical trial, patients with resectable thoracic esophageal squamous cell carcinoma can receive neoadjuvant immunotherapy and neoadjuvant chemotherapy before operation.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ni Zhang, Doctor | Contact | +8613006315393 | zhangnidoc@163.com | |
| Li Zhang, Doctor | Contact | +8613554081172 | luzigang@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tongji hospital | Recruiting | Wuhan | Hubei Provience | 430030 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23374478 | Background | Pennathur A, Gibson MK, Jobe BA, Luketich JD. Oesophageal carcinoma. Lancet. 2013 Feb 2;381(9864):400-12. doi: 10.1016/S0140-6736(12)60643-6. | |
| 26761210 | Background | Chen MF, Chen PT, Chen WC, Lu MS, Lin PY, Lee KD. The role of PD-L1 in the radiation response and prognosis for esophageal squamous cell carcinoma related to IL-6 and T-cell immunosuppression. Oncotarget. 2016 Feb 16;7(7):7913-24. doi: 10.18632/oncotarget.6861. |
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Tumor tissue samples will be taken before and after treatment for gene testing.
|
| 2-5 years |
| Overall survival | The time from randomization to death from any cause. | 2-5 years |
| Security | The safety of drugs was evaluated from four aspects: adverse events, adverse reactions, serious adverse events and serious adverse reactions. | 2-5 years |
| Objective Response Rate | The proportion of patients whose tumor volume reduced to a predetermined value and could maintain the minimum time limit. | 2-5 years |
| 2-5 years |
| Intestinal flora | Intestinal flora homeostasis is called the organ of human body. Intestinal flora homeostasis plays an important role in the life activities of the body. It has important physiological significance in promoting the digestion and absorption of host nutrients, maintaining the normal physiological function of intestine, regulating body immunity and antagonizing the colonization of pathogenic microorganisms. | 2-5 years |
| 27120796 | Background | Chen K, Cheng G, Zhang F, Zhang N, Li D, Jin J, Wu J, Ying L, Mao W, Su D. Prognostic significance of programmed death-1 and programmed death-ligand 1 expression in patients with esophageal squamous cell carcinoma. Oncotarget. 2016 May 24;7(21):30772-80. doi: 10.18632/oncotarget.8956. |
| 21684205 | Result | Sjoquist KM, Burmeister BH, Smithers BM, Zalcberg JR, Simes RJ, Barbour A, Gebski V; Australasian Gastro-Intestinal Trials Group. Survival after neoadjuvant chemotherapy or chemoradiotherapy for resectable oesophageal carcinoma: an updated meta-analysis. Lancet Oncol. 2011 Jul;12(7):681-92. doi: 10.1016/S1470-2045(11)70142-5. Epub 2011 Jun 16. |
| 7959579 | Result | Apinop C, Puttisak P, Preecha N. A prospective study of combined therapy in esophageal cancer. Hepatogastroenterology. 1994 Aug;41(4):391-3. |
| 8672151 | Result | Walsh TN, Noonan N, Hollywood D, Kelly A, Keeling N, Hennessy TP. A comparison of multimodal therapy and surgery for esophageal adenocarcinoma. N Engl J Med. 1996 Aug 15;335(7):462-7. doi: 10.1056/NEJM199608153350702. |
| 11208820 | Result | Urba SG, Orringer MB, Turrisi A, Iannettoni M, Forastiere A, Strawderman M. Randomized trial of preoperative chemoradiation versus surgery alone in patients with locoregional esophageal carcinoma. J Clin Oncol. 2001 Jan 15;19(2):305-13. doi: 10.1200/JCO.2001.19.2.305. |
| 15151953 | Result | Lee JL, Park SI, Kim SB, Jung HY, Lee GH, Kim JH, Song HY, Cho KJ, Kim WK, Lee JS, Kim SH, Min YI. A single institutional phase III trial of preoperative chemotherapy with hyperfractionation radiotherapy plus surgery versus surgery alone for resectable esophageal squamous cell carcinoma. Ann Oncol. 2004 Jun;15(6):947-54. doi: 10.1093/annonc/mdh219. |
| 16129366 | Result | Burmeister BH, Smithers BM, Gebski V, Fitzgerald L, Simes RJ, Devitt P, Ackland S, Gotley DC, Joseph D, Millar J, North J, Walpole ET, Denham JW; Trans-Tasman Radiation Oncology Group; Australasian Gastro-Intestinal Trials Group. Surgery alone versus chemoradiotherapy followed by surgery for resectable cancer of the oesophagus: a randomised controlled phase III trial. Lancet Oncol. 2005 Sep;6(9):659-68. doi: 10.1016/S1470-2045(05)70288-6. |
| 18309943 | Result | Tepper J, Krasna MJ, Niedzwiecki D, Hollis D, Reed CE, Goldberg R, Kiel K, Willett C, Sugarbaker D, Mayer R. Phase III trial of trimodality therapy with cisplatin, fluorouracil, radiotherapy, and surgery compared with surgery alone for esophageal cancer: CALGB 9781. J Clin Oncol. 2008 Mar 1;26(7):1086-92. doi: 10.1200/JCO.2007.12.9593. |
| 26254683 | Result | Shapiro J, van Lanschot JJB, Hulshof MCCM, van Hagen P, van Berge Henegouwen MI, Wijnhoven BPL, van Laarhoven HWM, Nieuwenhuijzen GAP, Hospers GAP, Bonenkamp JJ, Cuesta MA, Blaisse RJB, Busch ORC, Ten Kate FJW, Creemers GM, Punt CJA, Plukker JTM, Verheul HMW, Bilgen EJS, van Dekken H, van der Sangen MJC, Rozema T, Biermann K, Beukema JC, Piet AHM, van Rij CM, Reinders JG, Tilanus HW, Steyerberg EW, van der Gaast A; CROSS study group. Neoadjuvant chemoradiotherapy plus surgery versus surgery alone for oesophageal or junctional cancer (CROSS): long-term results of a randomised controlled trial. Lancet Oncol. 2015 Sep;16(9):1090-1098. doi: 10.1016/S1470-2045(15)00040-6. Epub 2015 Aug 5. |
| 26808342 | Result | Chen W, Zheng R, Baade PD, Zhang S, Zeng H, Bray F, Jemal A, Yu XQ, He J. Cancer statistics in China, 2015. CA Cancer J Clin. 2016 Mar-Apr;66(2):115-32. doi: 10.3322/caac.21338. Epub 2016 Jan 25. |
| 26623522 | Result | Lim SH, Hong M, Ahn S, Choi YL, Kim KM, Oh D, Ahn YC, Jung SH, Ahn MJ, Park K, Zo JI, Shim YM, Sun JM. Changes in tumour expression of programmed death-ligand 1 after neoadjuvant concurrent chemoradiotherapy in patients with squamous oesophageal cancer. Eur J Cancer. 2016 Jan;52:1-9. doi: 10.1016/j.ejca.2015.09.019. Epub 2015 Nov 26. |
| 29358502 | Result | Huang J, Xu B, Mo H, Zhang W, Chen X, Wu D, Qu D, Wang X, Lan B, Yang B, Wang P, Zhang H, Yang Q, Jiao Y. Safety, Activity, and Biomarkers of SHR-1210, an Anti-PD-1 Antibody, for Patients with Advanced Esophageal Carcinoma. Clin Cancer Res. 2018 Mar 15;24(6):1296-1304. doi: 10.1158/1078-0432.CCR-17-2439. Epub 2018 Jan 22. |
| 40531216 | Derived | Deng S, Wang Q, Li Y, Zhang R, Li J, Zhang Y, Cai Y, Sun W, Chang J, Zhang N, Zhang L. Clinical efficacy and biomarkers of neoadjuvant chemoimmunotherapy in locally advanced esophageal squamous cell carcinoma. Cancer Immunol Immunother. 2025 Jun 18;74(8):243. doi: 10.1007/s00262-025-04099-9. |
| 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 |
| 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 |
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| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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