Clinical trial · Interventional
PD-1 Inhibitor Combined With Radiotherapy for Elderly ESCC
Efficacy and Safety of PD-1 Inhibitor Combined With Radiotherapy in Treatment of Elderly Esophageal Squamous Cell Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Squamous Cell Carcinoma | Esophageal Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PD-1 inhibitor 200mg per three to four weeks, for one year | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experiment Arm
- description
- PD-1 inhibitor combined with radiotherapy
- interventionNames
- Drug: PD-1 inhibitor 200mg per three to four weeks, for one year
Primary outcomes (1)
- measure
- Progression-free survival
- timeFrame
- Two years
- description
- The time from the start of treatment to disease progression as assessed by the treating physicians in the study (investigator-assessed)
Secondary outcomes (1)
- measure
- Overall Survival
- timeFrame
- Three years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (0)
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