The Value of Sintilimab Consolidation Therapy After Definitive Concurrent Chemoradiotherapy for Locally Advanced Thoracic Esophageal Cancer
NCT ID: NCT04212598
Last Updated: 2024-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
40 participants
INTERVENTIONAL
2020-08-03
2024-11-04
Brief Summary
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Detailed Description
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Immune checkpoint inhibitors are a new class of antitumor drugs. They are different from traditional cytotoxic chemotherapy drugs and can target the regulatory molecules that play an inhibitory role in the tumor immune system.
Recent clinical studies had shown that for locally advanced non-small cell lung cancer, maintenance therapy with the immune checkpoint inhibitor could significantly improve the overall survival for locally advanced non-small cell lung cancer after definitive concurrent chemoradiotherapy. Moreover, the immune checkpoint inhibitor PD-1 has also been shown to be a promising anticancer agent in esophageal cancers. Therefore, the present study intended to give a standard dose (50.4Gy/28F) to locally advanced esophageal squamous cell carcinoma for radical chemoradiotherapy, and than to give the Sintilimab as consolidation therapy for 1 year after completion of radiotherapy. At the time point of 6 weeks after radiotherapy, all participates need a full evaluation of the treatment response. In patients with residual disease, we would give them an additional radiotherapy boost to 61.2 Gy/34F under the guidance of PET-CT or ultrasound endoscopy.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Definitive concurrent chemoradiotherapy or radiotherapy arm
Patients who completed concurrent chemoradiotherapy standard dose would received the Sintilimab as a consolidate therapy for one year.
Sintilimab
Patients who completed concurrent chemoradiotherapy standard dose would received the Sintilimab as a consolidate therapy for one year.
Interventions
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Sintilimab
Patients who completed concurrent chemoradiotherapy standard dose would received the Sintilimab as a consolidate therapy for one year.
Eligibility Criteria
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Inclusion Criteria
* Stage II/III esophageal cancer;
* Pathology confirmed squamous cell carcinoma;
* Hemoglobin ≥10g/dl, WBC ≥3.0 x 109/L, platelet ≥100 x 109/L; CR≤ 1.0x normal upper limit, total bilirubin ≤ 1.5x normal upper limit, AST and ALT≤ 1.5x normal upper limit, AKP≤ 2.5x normal upper limit;
* Have a full understanding of this study, participate voluntarily, have follow-up conditions and sign the informed consent;
Exclusion Criteria
* Esophageal adenocarcinoma;
* Gastric esophageal junction adenocarcinoma;
* ECOG \> 2;
* Progression after first-course radiotherapy;
* Existing active infection, such as active tuberculosis, hepatitis, etc.;
18 Years
70 Years
ALL
No
Sponsors
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Wuhan University
OTHER
Responsible Party
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Conghua Xie,MD,PhD
Director, Head of Radiation and Medical Oncology
Principal Investigators
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Conghua Xie, MD
Role: STUDY_DIRECTOR
Zhongnan Hospital
Locations
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Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China
Countries
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References
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Siegel RL, Miller KD, Jemal A. Cancer Statistics, 2017. CA Cancer J Clin. 2017 Jan;67(1):7-30. doi: 10.3322/caac.21387. Epub 2017 Jan 5.
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.
Cooper JS, Guo MD, Herskovic A, Macdonald JS, Martenson JA Jr, Al-Sarraf M, Byhardt R, Russell AH, Beitler JJ, Spencer S, Asbell SO, Graham MV, Leichman LL. Chemoradiotherapy of locally advanced esophageal cancer: long-term follow-up of a prospective randomized trial (RTOG 85-01). Radiation Therapy Oncology Group. JAMA. 1999 May 5;281(17):1623-7. doi: 10.1001/jama.281.17.1623.
Minsky BD, Pajak TF, Ginsberg RJ, Pisansky TM, Martenson J, Komaki R, Okawara G, Rosenthal SA, Kelsen DP. INT 0123 (Radiation Therapy Oncology Group 94-05) phase III trial of combined-modality therapy for esophageal cancer: high-dose versus standard-dose radiation therapy. J Clin Oncol. 2002 Mar 1;20(5):1167-74. doi: 10.1200/JCO.2002.20.5.1167.
Suh YG, Lee IJ, Koom WS, Cha J, Lee JY, Kim SK, Lee CG. High-dose versus standard-dose radiotherapy with concurrent chemotherapy in stages II-III esophageal cancer. Jpn J Clin Oncol. 2014 Jun;44(6):534-40. doi: 10.1093/jjco/hyu047. Epub 2014 Apr 24.
Zhang Z, Liao Z, Jin J, Ajani J, Chang JY, Jeter M, Guerrero T, Stevens CW, Swisher S, Ho L, Yao J, Allen P, Cox JD, Komaki R. Dose-response relationship in locoregional control for patients with stage II-III esophageal cancer treated with concurrent chemotherapy and radiotherapy. Int J Radiat Oncol Biol Phys. 2005 Mar 1;61(3):656-64. doi: 10.1016/j.ijrobp.2004.06.022.
Other Identifiers
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Immune consolidation therapy
Identifier Type: -
Identifier Source: org_study_id