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NCT Number: NCT04822103

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Guangdong Provincial People's Hospital, Guangzhou, Guangdong, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Objective Response Rate (ORR)

    Time frame: Up to 24 weeks

    Objective Response Rate

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

    Time frame: Up to 12 weeks

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

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

    Time frame: Up to 36 weeks

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

Secondary outcomes

  1. Pathologic complete response rate (pCR)

    Time frame: Three to five working days after surgery

    The rate of pathologic complete response rate after the combined treatment of chemotherapy and immunotherapy following surgery

  2. R0 resection rate

    Time frame: Three to five working days after surgery

    The R0 resection rate of esophagectomy

  3. Overall survival

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

    Overall survival rate

  4. Event-free survival

    Time frame: 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

    EFS

  5. Major pathological response

    Time frame: Three to five working days after surgery

    ≤10% residual viable tumor follow NAIC

Sponsors and collaborators

Lead sponsor

Guangdong Provincial People's Hospital

Other

Collaborators

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

Registry information

Official study title

A Real-World Study Evaluating the Effectiveness and Safety of Immune Checkpoint Inhibitors and Chemotherapy for Advanced Esophageal Cancer

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 30, 2021
Registry last updated
Mar 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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