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Trial Title:
MRD-Guided Consolidation Therapy Following Definitive Radiotherapy in Esophageal Cancer
NCT ID:
NCT06498752
Condition:
Esophageal Cancer
Conditions: Official terms:
Esophageal Neoplasms
Antibodies
Antibodies, Monoclonal
Conditions: Keywords:
Esophageal squamous cell carcinoma
Immune checkpoint inhibitor
immunotherapy
chemotherapy; radiotherapy
Minimal residual disease, MRD
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
PD-1 monoclonal antibody consolidation therapy
Description:
PD-1 monoclonal antibody-based consolidation therapy for 1 year after completion of
radiotherapy (or combination chemotherapy up to 4 cycles if less than 4 cycles of
chemotherapy). Specific dosing: PD-1 monoclonal antibody, 200mg every 3 weeks.
Arm group label:
MRD positive
Summary:
To further validate the performance of the high-sensitivity MRD assay in patients with
squamous esophageal cancer who have completed radical radiotherapy; to validate whether
MRD-negative patients can maintain a good prognosis under regular follow-up; and to
validate whether MRD-positive patients can improve their survival with consolidation
therapy with PD-1 monotherapy.
Detailed description:
Esophageal cancer is one of the most common lethal tumours in the world and accounts for
more than 50% of new cases in China. Definitive concurrent chemoradiotherapy is the
standard treatment for unresectable locally advanced esophageal cancer, and the 5-year
survival rate is only about 30%, but due to the lack of evidence, consolidation therapy
has not been explicitly recommended in major guidelines.
In the CheckMate 577 study, patients who did not achieve pathological complete response
(pCR) after surgery improved their survival through immunology consolidation therapy with
PD-1 monotherapy, suggesting that patients who did not achieve clinical complete response
(cCR) after radiotherapy may benefit from immunology consolidation therapy. This suggests
that patients who do not have a clinical complete response (cCR) after radiotherapy are
likely to benefit from immunology consolidation therapy. Patients with cCR after
radiotherapy may achieve similar results to those achieved with radical surgery, and
consolidation is probably not necessary.
However, existing clinical practice is unable to accurately determine the efficacy of
radiotherapy in esophageal cancer, making risk-of-recurrence-guided stratified
consolidation strategies difficult to achieve. Most of the ongoing
radiotherapy-immunotherapy studies in esophageal cancer have been designed to treat all
patients indiscriminately with immunology consolidation therapy, which may lead to
over-treatment of cCR patients.
Therefore, there is an urgent need to find easily accessible and reliable biomarkers for
the efficacy of radiotherapy in esophageal cancer, and to carry out prospective clinical
studies as soon as possible, so as to optimize the strategy of consolidation therapy
after radiotherapy in esophageal cancer. The high sensitivity of minimal residual disease
(MRD) detection technology established by the researcher's team provides a prerequisite
for this.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. ≥18 years, any gender
2. Histologically or cytologically confirmed squamous cell carcinoma of esophageal
cancer. The initial clinical stage is I-VIa (2018 AJCC Cancer Staging Manual, 8th
Edition) , primary unresectable oesophageal cancer
3. ECOG performance status <= 1.
4. No significant abnormality in laboratory routine indicators such as blood routine
and liver and kidney function
5. Completed radical radiotherapy (dose 50-60Gy);
6. Received a systemic regimen of platinum in combination with paclitaxel or a
5-FU-based two-drug regimen with or without PD-1 monotherapy in accordance with the
CSCO guidelines, and S-1 monotherapy in elderly patients;
7. Informed consent
Exclusion Criteria:
1. Patients with other cancer history except hypopharyngeal carcinoma in situ,
non-malignant skin cancer and cervical carcinoma in situ.
2. Active infection currently exists, serious illness such as myocardial infarction in
the 6 months prior to enrolment
3. History of autoimmune diseases
4. Participate in other clinical trials at present or within 4 weeks before enrollment;
5. Received systemic therapy (chemotherapy alone or chemotherapy combined with
immunotherapy) for more than 4 cycles.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Cancer hospital, CAMS
Address:
City:
Beijing
Zip:
100021
Country:
China
Status:
Recruiting
Contact:
Last name:
Wen-Yang Liu, MD
Phone:
+86-01087787654
Email:
liuwenyang@cicams.ac.cn
Contact backup:
Phone ext:
Liu
Email:
liuwenyang@cicams.ac.cn
Investigator:
Last name:
Wen-Yang Liu
Email:
Principal Investigator
Start date:
July 16, 2024
Completion date:
June 2025
Lead sponsor:
Agency:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Agency class:
Other
Collaborator:
Agency:
Peking University Cancer Hospital & Institute
Agency class:
Other
Collaborator:
Agency:
Hebei Medical University Fourth Hospital
Agency class:
Other
Collaborator:
Agency:
Tianjin Medical University Cancer Institute and Hospital
Agency class:
Other
Source:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06498752
