Clinical trial NCT04822103: A Real-World Study of Immune Checkpoint Inhibitors and Chemotherapy for Advanced Esophageal Cancer
Official title: A Real-World Study Evaluating the Effectiveness and Safety of Immune Checkpoint Inhibitors and Chemotherapy for Advanced Esophageal Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Esophageal Cancer
Keywords: esophageal cancer
real-world study
immunotherapy
chemotherapy
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
Collaborators: name: The People's Hospital of Gaozhou
name: The General Hospital of Southern Theater Command
name: Affiliated Cancer Hospital & Institute of Guangzhou Medical University
name: First Affiliated Hospital of Shantou University Medical College
name: First Affiliated Hospital, Sun Yat-Sen University
name: Shantou Central Hospital
name: Shenzhen People's Hospital
First posted: 2021-03-30
Enrollment: 155
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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.


Eligibility criteria: 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

Primary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: Up to 24 weeks
measure: Safety as measured by number of participants with Grade 3 and 4 adverse events
timeFrame: Up to 12 weeks
measure: Feasibility of immunochemotherapy defined as at least 80% of the patients completed all planned courses
timeFrame: Up to 36 weeks
Secondary outcomes:
measure: Pathologic complete response rate (pCR)
timeFrame: Three to five working days after surgery
measure: R0 resection rate
timeFrame: Three to five working days after surgery
measure: Overall survival
timeFrame: from the date of diagnosis to the date of death, assessed up to 100 months
measure: Event-free survival
timeFrame: 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
measure: Major pathological response
timeFrame: Three to five working days after surgery
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
city: Shantou
country: China
facility: Shantou Central Hospital
state: Guangdong
Study officials:
affiliation: Guangdong Provincial People's Hospital
name: Guibin Qiao, MD
role: PRINCIPAL_INVESTIGATOR
References: