The Value of Sintilimab Consolidation Therapy After Definitive Concurrent Chemoradiotherapy for Locally Advanced Thoracic Esophageal Cancer

NCT04212598 | Completed Phase 2

• 1 other identifier: Immune consolidation therapy
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Esophageal cancer is a kind of disease with high incidence and mortality. Definitive concurrent chemoradiotherapy is an important treatment for locally advanced esophageal squamous cell carcinoma. To Investigate the value of immunotherapy consolidation in locally advanced esophageal squamous cell carcinoma after completing radical concurrent chemoradiotherapy.

Conditions

Esophageal Squamous Cell Carcinoma

Keywords

Chemoradiotherapy; Esophageal Squamous Cell Carcinoma; Immunotherapy

Outcome Measures

Primary Outcomes (1)

• Percentage of patients with disease progression within 2 years after treatment

  Progression-free survival is measured from the date of enrolling to the date of disease progression or death from any cause or final follow-up

  2-years

Secondary Outcomes (1)

• Percentage of patients who died within 2 years after treatment

  2-years

Other Outcomes (1)

• The number of patients with treatment-related toxicity between the treatment period and half a year after treatment

  0.5-year

Study Arms (1)

Definitive concurrent chemoradiotherapy or radiotherapy arm

EXPERIMENTAL

Patients who completed concurrent chemoradiotherapy standard dose would received the Sintilimab as a consolidate therapy for one year.

Drug: Sintilimab

Interventions

Sintilimab DRUG

Patients who completed concurrent chemoradiotherapy standard dose would received the Sintilimab as a consolidate therapy for one year.

Definitive concurrent chemoradiotherapy or radiotherapy arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ECOG 0-1; Life expectancy \>6 months;
• 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;

You may not qualify if:

• Stage IV esophageal cancer;
• Esophageal adenocarcinoma;
• Gastric esophageal junction adenocarcinoma;
• ECOG \> 2;
• Progression after first-course radiotherapy;
• Existing active infection, such as active tuberculosis, hepatitis, etc.;

Sponsors & Collaborators

• Wuhan University: lead

Study Sites (1)

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430071, China

Location

Related Publications (6)

• 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.

  PMID: 28055103 BACKGROUND

• 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.

  PMID: 26808342 BACKGROUND

• 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.

  PMID: 10235156 BACKGROUND

• 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.

  PMID: 11870157 BACKGROUND

• 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.

  PMID: 24771865 BACKGROUND

• 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.

  PMID: 15708243 BACKGROUND

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

sintilimab

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• Conghua Xie, MD

  Zhongnan Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Head of Radiation and Medical Oncology

Model Details: This is a single arm phase II study.

Study Record Dates

• First Submitted: December 21, 2019
• First Posted: December 27, 2019
• Study Start: August 3, 2020
• Primary Completion: November 3, 2024
• Study Completion: November 4, 2024
• Last Updated: December 10, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)