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Low-dose re-irradiation combined with chemotherapy and PD-1 for local primary-recurrence esophageal cancer: A prospective, single-arm clinical study

Low-dose re-irradiation combined with chemotherapy and PD-1 for local primary-recurrence esophageal cancer: A prospective, single-arm clinical study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400089694
Enrollment
Unknown
Registered
2024-09-13
Start date
2024-09-20
Completion date
Unknown
Last updated
2024-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

esophageal cancer

Interventions

Single arm group:re-irradiation combined with chemoimmunotherapy

Sponsors

Jiangsu Province Hospital, the first affiliated hospital of Nanjing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged between 18 and 80 years old; 2. The primary/primary focus was histologically diagnosed as esophageal squamous cell carcinoma; 3. Had previously received thoracic radiotherapy (>=50Gy), and imaging evaluation showed recurrence after radiotherapy; 4. The time interval between local recurrence and the end of the previous radiotherapy was more than 6 months; 5. The recurrent lesion was evaluated by thoracic surgery as an unresectable tumor, or the patient refused surgery, or the patient was evaluated to be unable to tolerate surgery for medical reasons; 6. KPS score is greater than or equal to 70, ECOG general status score is 0-1; 7. Adequate organ function and bone marrow function; 8. The location of the tumor should meet the requirements of the shooting field layout; Patients can lie on their back or stomach for more than 30 minutes in the position required for treatment.

Exclusion criteria

Exclusion criteria: 1. Complicated with other malignant tumors that have not been controlled; 2. The toxic side effects of the first radiotherapy have not recovered (including but not limited to: esophageal/tracheal fistula; radiation pneumonia; Class IV and above other toxic and side effects, etc.); 3. Previous radiotherapy of other organs in the chest; 4. Pacemakers or other metal implants that may be subject to high-energy radiation interference with normal function or that may affect the dose of the radiation target; 5. Accompanied by serious comorbidities that may affect radiotherapy; 6. Pregnant or lactating women; 7. Life expectancy is less than three months 8. The physician determines that further radiotherapy will not benefit the patient; 9. Inability to understand the purpose of treatment or unwillingness/inability to sign informed consent; 10. Other situations where participation in a clinical study is not considered appropriate by the physician.

Design outcomes

Secondary

MeasureTime frame
Survival time after recurrence;Overall survival;

Primary

MeasureTime frame
Objective Response Rate;Duration of remission;(Disease control rate;Safety;

Countries

China

Contacts

Public ContactXiaolin Ge

Jiangsu Province Hospital, the first affiliated hospital of Nanjing Medical University

doctorgxl@163.com+86 139 5181 8797

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026