MRD-guided therapy for esophageal cancer after radiotherapy
A Phase II Clinical Trial of Consolidation Therapy Guided by MRD Testing After Radical Radiotherapy for Esophageal Cancer
This study is testing if a special test can help doctors determine the best follow-up care for patients with squamous esophageal cancer after radiation treatment, by seeing if those with no remaining cancer cells do well with regular check-ups and if those with remaining cancer cells can live longer with extra treatment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 102 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06498752 on ClinicalTrials.gov |
What this trial studies
This study aims to validate the effectiveness of a high-sensitivity minimal residual disease (MRD) assay in patients with squamous esophageal cancer who have completed radical radiotherapy. It will assess whether MRD-negative patients can maintain a good prognosis with regular follow-up and whether MRD-positive patients can improve their survival through consolidation therapy using PD-1 monotherapy. The study seeks to refine treatment strategies by identifying which patients may benefit from additional therapy based on their MRD status.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with histologically confirmed squamous cell carcinoma of the esophagus who have completed radical radiotherapy.
Not a fit: Patients with other active cancers or significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more personalized treatment strategies that improve survival rates for patients with esophageal cancer.
How similar studies have performed: Previous studies, such as CheckMate 577, have shown that consolidation therapy can improve survival in similar patient populations, suggesting a promising avenue for this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Beijing, Beijing Municipality
- Cancer hospital, CAMS — Beijing, Beijing Municipality, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.