Adjuvant Immunotherapy for Esophageal Squamous Cell Carcinoma
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSichuan University
About this trial
Patients with esophageal cancer still face a high risk of recurrence after receiving neoadjuvant chemoradiotherapy (nCRT) combined with radical surgery, especially for those who do not achieve pathological complete response (non-pCR). Compared with the overall non-pCR population, the subgroup with lymph node positivity has a significantly worse prognosis. The CheckMate 577 study confirmed that in patients with locally advanced resectable esophageal cancer or esophageal-gastric junction cancer, adjuvant treatment with nivolumab after nCRT significantly prolonged disease-free survival compared with placebo (median DFS: 22.4 months vs 11.0 months; HR=0.69, p\<0.001).
The current research focus has expanded to the field of neoadjuvant chemoimmunotherapy, but the adjuvant treatment strategy after such therapy remains a blank slate. Given that esophageal squamous cell carcinoma (ESCC) is the predominant type of esophageal cancer in our country, it is of great clinical significance to explore adjuvant treatment strategies after neoadjuvant chemoimmunotherapy combined with radical resection.
Based on the above background, we have designed a randomized controlled trial (RCT) to evaluate the efficacy of adjuvant immunotherapy versus observation alone in patients with ESCC after neoadjuvant chemoimmunotherapy, with the hope of providing evidence-based medical evidence for this population.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged ≥18 years.
Histologically confirmed esophageal squamous cell carcinoma.
Preoperative staging of cT1b-cT2N+M0 or cT3-cT4a, any N, M0 (UICC/AJCC TNM staging, 8th edition, 2017), and treated with neoadjuvant therapy using an immunotherapy combined with a taxane and platinum regimen, followed by radical surgical resection.
R0 resection.
Disqualifiers
Presence of blood-borne infectious disease human immunodeficiency virus (HIV).
Presence of psychiatric disorders.
History of any other malignancy within the past 5 years (except for completely cured cervical carcinoma in situ or basal cell or squamous cell carcinoma of the skin).
Treatment in the ICU due to severe complications after radical surgery for esophageal cancer.
Trial design
Design model
Parallel
Treatments tested in this trial
Immune Checkpoint Inhibitors ( pembrolizumab, tislelizumab, sintilimab, camrelizumab, and toripalimab)
DrugThe immune checkpoint inhibitors used for adjuvant therapy after surgery were consistent with those used during the neoadjuvant treatment before surgery, including pembrolizumab, tislelizumab, sintilimab, camrelizumab, and toripalimab.
Observation
Other interventionPostoperative observation is conducted without the use of any anti-tumor treatment.
Treatment groups
98 Participants
are divided into 2 treatment groupsGroup A: Adjuvant Immunotherapy GroupExperimental treatment 1 intervention
Group B: Observation GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Disease-Free Survival (DFS)
In this study, disease-free survival (DFS) refers to the time from the start of surgery to the first occurrence of disease recurrence or metastasis. If a patient does not experience disease recurrence or metastasis during the follow-up period, their DFS is typically recorded as the time from the start of treatment to the end of follow-up.
Time frame
From the time of patient enrollment, up to a maximum of 2 years.Secondary outcomes
1
Overall Survival (OS)
Overall Survival (OS) refers to the time from the start of enrollment to the time of death from any cause. If a patient is still alive at the end of the study, their OS is recorded as the time from the start of the study to the end of the study.
Time frame
From the time of patient enrollment, up to a maximum of 5 years.Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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