NCT06186609 PD-1 Inhibitor Combined With Radiotherapy for Elderly ESCC
| NCT ID | NCT06186609 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Affiliated Hospital of Nantong University |
| Condition | Esophageal Squamous Cell Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 68 participants |
| Start Date | 2023-07-01 |
| Primary Completion | 2025-06-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 68 participants in total. It began in 2023-07-01 with a primary completion date of 2025-06-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Concurrent chemoradiotherapy is now considered to be the standard treatment modality for esophageal cancer patients who are medically unfit for surgery. However, elderly patients have limitations in their ability to tolerate concurrent chemoradiotherapy in comparison to nonelderly patients because of medical comorbidities and reduced functional reserve of organs. Immune checkpoint inhibitors, including PD-1 inhibitor, have been used in a large number of clinical studies on esophageal cancer and have achieved certain results. PD-1 inhibitor combined with radiotherapy may be a new strategy for elderly patients with esophageal cancer. This study aims to explore the efficacy and safety of PD-1 inhibitor combined with radiotherapy in the treatment of elderly patients with esophageal cancer. PD-1 inhibitor was delivered 200mg once before radiotherapy and 200mg every 3-4 weeks after radiotherapy for one year.
Eligibility 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.
Contact & Investigator
Yu Weiwei
PRINCIPAL INVESTIGATOR
Department of Radiation Oncology, Affiliated Hospital of Nantong University
Frequently Asked Questions
Who can join the NCT06186609 clinical trial?
This trial is open to participants of all sexes, aged 70 Years or older, studying Esophageal Squamous Cell Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06186609 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06186609 currently recruiting?
Yes, NCT06186609 is actively recruiting participants. Contact the research team at yww333@126.com for enrollment information.
Where is the NCT06186609 trial being conducted?
This trial is being conducted at Nantong, China.
Who is sponsoring the NCT06186609 clinical trial?
NCT06186609 is sponsored by Affiliated Hospital of Nantong University. The principal investigator is Yu Weiwei at Department of Radiation Oncology, Affiliated Hospital of Nantong University. The trial plans to enroll 68 participants.