A Real-World Study of Immune Checkpoint Inhibitors and Chemotherapy for Advanced Esophageal Cancer

NCT04822103 | Completed DMC

• 1 other identifier: RICE-retro
• Study Type: observational
• Target: 155
• Locations: 1 country
• Sites: 2

Brief Summary

The role of preoperative chemotherapy as standard therapy is well-established for advanced esophageal cancer. Immunotherapeutic agents such as Immune checkpoint inhibitors has been shown to improve objective response rate in solid tumors. However, there is a paucity of data regarding the efficacy and safety of preoperative immunotherapy plus chemotherapy in esophageal cancer patients in real-world practice. This study set out to investigate whether the combination of preoperative chemotherapy and immune checkpoint inhibitors is beneficial to improve the objective response rate as well as the pathological complete response rate in a real-world scenario.

Conditions

Esophageal Cancer

Keywords

esophageal cancer; real-world study; immunotherapy; chemotherapy

Outcome Measures

Primary Outcomes (3)

• Objective Response Rate (ORR)

  Objective Response Rate

  Up to 24 weeks

• Safety as measured by number of participants with Grade 3 and 4 adverse events

  Number of Grade 3 and 4 adverse events as defined by CTCAE v5.0

  Up to 12 weeks

• Feasibility of immunochemotherapy defined as at least 80% of the patients completed all planned courses

  The feasibility of immunochemotherapy was defined as at least 80% of the patients completed all planned courses.

  Up to 36 weeks

Secondary Outcomes (5)

• Pathologic complete response rate (pCR)

  Three to five working days after surgery

• R0 resection rate

  Three to five working days after surgery

• Overall survival

  from the date of diagnosis to the date of death, assessed up to 100 months

• Event-free survival

  from the date of treatment initiation to the date of first progression (local recurrence of tumor or distant metastasis) or death from any cause, assessed up to 100 months

• Major pathological response

  Three to five working days after surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed as potentially resectable (including initially-unresectable) esophageal squamous cell carcinoma via pathological specimen, KPS ≥ 80, has adequate organ function and no distant metastasis are included in the study

You may qualify if:

• Pathologically diagnosed as esophageal squamous cell carcinoma
• KPS≥80
• Adequate organ function
• No distant metastasis
• The diseases could be resected or potentially resectable after immunochemotherapy assessed by a thoracic oncologist

You may not qualify if:

• incomplete medical record which affects statistical analysis
• have participated in previous interventional clinical trials
• other situations evaluated by investigators not meet the enrollment

Sponsors & Collaborators

• Guangdong Provincial People's Hospital: lead
• The People's Hospital of Gaozhou: collaborator
• The General Hospital of Southern Theater Command: collaborator
• Affiliated Cancer Hospital & Institute of Guangzhou Medical University: collaborator
• First Affiliated Hospital of Shantou University Medical College: collaborator
• First Affiliated Hospital, Sun Yat-Sen University: collaborator
• Shantou Central Hospital: collaborator
• Shenzhen People's Hospital: collaborator

Study Sites (2)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510080, China

Location

Shantou Central Hospital

Shantou, Guangdong, 515031, China

Location

Related Publications (1)

• Yang W, Ma SC, Fang Z, Liu Y, Zhang X, Wang F, Wang C, Wang Y, Wang X, Chen W, Luo H, Yang L, Zhang S, Zeng B, Liu Z, Ou Q, Cai J, Yeung SJ, Cheng C. TP53-centric ctDNA complements PET/CT for non-invasive assessment of pathological complete response and survival after neoadjuvant immunochemotherapy in esophageal squamous cell carcinoma: a prospective cohort study. Int J Surg. 2025 May 1;111(5):3256-3268. doi: 10.1097/JS9.0000000000002341.

  PMID: 40146232 DERIVED

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• Guibin Qiao, MD

  Guangdong Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2021
• First Posted: March 30, 2021
• Study Start: January 1, 2021
• Primary Completion: October 1, 2021
• Study Completion: October 31, 2021
• Last Updated: March 18, 2022

Record last verified: 2022-03

Locations

CN (2)