Combining PD-1 inhibitors with radiotherapy for elderly patients with esophageal cancer
Efficacy and Safety of PD-1 Inhibitor Combined With Radiotherapy in Treatment of Elderly Esophageal Squamous Cell Cancer
This study is testing if a new treatment combining a PD-1 inhibitor with radiotherapy can help older patients with esophageal cancer who can't handle standard treatments.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 68 (estimated) |
| Ages | 70 Years and up |
| Sex | All |
| Sponsor | Affiliated Hospital of Nantong University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Nantong, Jiangsu) |
| Trial ID | NCT06186609 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the safety and efficacy of a PD-1 inhibitor combined with radiotherapy specifically for elderly patients suffering from esophageal squamous cell carcinoma. The study targets patients aged 70 and above who are unable to tolerate standard concurrent chemoradiotherapy due to medical comorbidities. Participants will receive a PD-1 inhibitor before and after radiotherapy over the course of one year. The goal is to determine if this combination can provide a viable treatment option for this vulnerable population.
Who should consider this trial
Good fit: Ideal candidates are patients aged 70 years or older with stage II to IVA esophageal squamous cell carcinoma who have not undergone prior surgery, radiotherapy, or chemotherapy.
Not a fit: Patients with severe autoimmune diseases, significant organ dysfunction, or those who have previously received treatment for esophageal cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could offer a safer and more effective treatment alternative for elderly patients with esophageal cancer.
How similar studies have performed: While PD-1 inhibitors have shown promise in treating various cancers, this specific combination with radiotherapy for elderly patients is a novel approach that has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients aged 70 years or above 2. Treatment naive patients with pathology proven esophageal squamous cell carcinoma that was inoperable or refuse surgery and who could not tolerate concurrent chemoradiotherapy 3. Stage II-IVa according to the AJCC TNM staging system 4. Estimated survival time ≥ 3 months 5. Karnofsky performance score ≥70 6. Normal blood routine, liver and kidney function less than 2 times of the normal upper limit 7. Without mental disorders, cooperate with treatment and follow-up 8. Have fully understood this study and voluntarily signed the informed consent Exclusion Criteria: 1. Esophageal bronchial fistula or esophageal mediastinal fistula 2. Patients who have participated in other clinical trials before this treatment 3. Severe heart, liver and/or kidney dysfunction 4. Serious infectious diseases 5. EC who has received surgery, chemotherapy,PD-1 inhibitor or radiotherapy 6. Severe autoimmune disease 7. Relapse disease or distant metastasis 8. Combined with other malignant tumors.
Where this trial is running
Nantong, Jiangsu
- Affiliated Hospital of Nantong University — Nantong, Jiangsu, China (Recruiting)
Study contacts
- Principal investigator: Yu Weiwei — Department of Radiation Oncology, Affiliated Hospital of Nantong University
- Study coordinator: Yu Weiwei
- Email: yww333@126.com
- Phone: 18930174528
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.