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

Esophageal Squamous Cell Carcinoma Clinical Trial

Official title:

The Value of Sintilimab Consolidation Therapy After Definitive Concurrent Chemoradiotherapy for Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma, an Open, Prospective, Single-arm Phase II Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04212598
• Other study ID #: Immune consolidation therapy
• Status: Recruiting
• Phase: Phase 2
• Start date: August 3, 2020
• Est. completion date: December 3, 2023

Study information

• Verified date: April 2023
• Source: Wuhan University
• Contact: Conghua Xie, MD
• Phone: 02767812510
• Email: chxie_65[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

In East countries, especially China, more than 75 percent of esophageal cancers are primary squamous cell cancers located in the middle and upper thoracic segments, whereas adenocarcinoma accounted for less than 20 percent.Unlike other malignancies, more than half of esophageal cancer were diagnosed as locally advanced at the time of diagnosis. Definitive concurrent chemoradiotherapy is an important treatment for locally advanced esophageal squamous cell carcinoma.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 3, 2023
• Est. primary completion date: August 4, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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;

Exclusion Criteria:

• 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.;

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Esophageal Squamous Cell Carcinoma

Intervention

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

Locations

Country	Name	City	State
China	Zhongnan Hospital of Wuhan University	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Wuhan University

Country where clinical trial is conducted

China, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The number of patients with treatment-related toxicity between the treatment period and half a year after treatment	Acute toxicities were scored according to the Common Toxicity Criteria for Adverse Events, version 3.0 (National Cancer Institute, NCI, Rockville, MD).	0.5-year
Primary	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	Percentage of patients who died within 2 years after treatment	Progression-free survival is measured from the date of enrolling to the date of death from any cause or final follow-up	2-years