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Phase II clinical study of carbon ion radical radiotherapy for esophageal cancer

Phase II clinical study of carbon ion radical radiotherapy for esophageal cancer

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100053860
Enrollment
Unknown
Registered
2021-12-01
Start date
2021-12-01
Completion date
Unknown
Last updated
2022-10-31

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

Conditions

esophageal cancer

Interventions

Group A:T1-2, T2 length does not exceed 0.5cm
Group B:Mixed irradiation group, wide range of T2, more than 0.5cm and T3-4

Sponsors

Wuwei Tumor Hospital Heavy Ion Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Pathologically confirmed squamous or adenocarcinoma; 2. AJCC 2017 Eighth Edition cT1-4 any N M0; 3. No distant metastasis to solid organs; 4. Never received radiation therapy for esophageal cancer; 5. No history of other malignant tumors (except for cured skin cancer and stage zero cervical cancer); 6. Kidney function, liver function and bone marrow function are basically normal (serum creatinine 9.5 g/dL; white blood cell count, >= 3000/mL; platelet count >= 100,000/mL); 7. Aged more than 18 years old and less than 80 years old; 8. Good physical condition, that is, ECOG (Eastern Cooperative Oncology Group) = 6 months; 10. Before radiotherapy, the patient or his legal representative has signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients who have esophagotracheal fistula or who are highly likely to have esophagotracheal fistula as judged by physicians; 2. Lose more than 20% of body weight within six months; 3. Pregnancy (confirmed by serum or urine ß-HCG test) or during lactation; 4. Drug or alcohol dependence; 5. AIDS patients; 6. With uncontrolled systemic, pulmonary or cardiac disease; 7. Accompanied by serious comorbidities that make the trial program unable to proceed smoothly, including uncontrolled comorbidities (inadequate pulmonary function, cardiovascular, pulmonary, liver, kidney, diabetes, etc.), addiction and/or mental illness; 8. Implantation of a pacemaker or other metal prosthesis is sufficient to affect the conduct of radiation therapy; 9. Patients with poor compliance, including those who may not be able to complete the treatment plan, or who cannot receive the prescribed follow-up and examination; 10. Had other malignant tumors (except non-malignant melanoma skin cancer or non-invasive cervical cancer); 11. Receive systemic immunotherapy or corticosteroid therapy at the same time; 12. Serum creatinine clearance rate < 30ml/min; 13. Contraindications to radiotherapy; 14. Participated in clinical trials of other drugs within 30 days before enrolling in this trial; 15. No capacity for civil conduct or limited capacity for civil conduct; 16. Any medical history, according to the investigator's judgment, may interfere with the test results or increase the risk to the patient; 17. Any circumstances that the physician considers inappropriate to participate in the trial.

Design outcomes

Primary

MeasureTime frame
Local tumor control rate;Objective tumor response rate (ORR);

Secondary

MeasureTime frame
Event free survival;Progression free survival (DFS);Overall survival (OS);

Countries

China

Contacts

Public ContactZhang Yanshan

Wuwei Tumor Hospital Heavy Ion Center

13830510999@163.com+86 13830510999

Outcome results

None listed

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