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A prospective phase II clinical study on locally advanced esophageal cancer treated with concurrent chemotherapy and mixed radiotherapy (carbon ion plus photon radiation)

A prospective phase II clinical study on locally advanced esophageal cancer treated with concurrent chemotherapy and mixed radiotherapy (carbon ion plus photon radiation)

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300067367
Enrollment
Unknown
Registered
2023-01-05
Start date
2023-01-05
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

esophageal cancer

Interventions

Experimental group:concurrent chemotherapy and mixed radiotherapy (carbon ion plus photon radiation)

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 cT1-4anyNM0; 3. No distant metastasis to solid organs; 4. Never received any treatment for esophageal cancer; 5. No history of other malignant tumors (except cured skin cancer and stage zero cervical cancer); 6. Renal 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. Age greater than 18 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 already had esophageal and tracheal fistulas or have been judged by doctors to be very likely to have esophageal and tracheal fistulas; 2. Weight loss of more than 20% within six months; 3. During pregnancy (confirmed by serum or urine ß-HCG test) or during lactation; 4. Drug abuse or alcohol dependence; 5. AIDS patients; 6. With uncontrolled systemic, pulmonary or cardiac disease; 7. Accompanied by serious comorbidities that prevent the trial program from being carried out smoothly, including uncontrolled comorbid diseases (insufficient lung function, cardiovascular, lung, liver, kidney, diabetes, etc.), addiction and/or mental illness; 8. Implantation of a pacemaker or other metal prosthesis is enough to affect the progress of radiation therapy; 9. Patients with poor compliance, including those who may not be able to complete the treatment plan, or cannot accept the prescribed follow-up visits and examinations; 10. Have suffered from 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 < 30 ml/min; 13. Contraindications to radiation therapy; 14. Participated in other drug clinical trials within 30 days before enrollment in this trial; 15. No contraindication capacity for civil conduct radiotherapy or limited capacity for civil conduct; 16. Any medical history that, according to the investigator's judgment, may interfere with the test results or increase the risk of the patient; 17. Any situation that the doctor thinks is not suitable for participating in the trial; 18. The patient refuses to sign the informed consent.

Design outcomes

Primary

MeasureTime frame
2-year local control rate;

Secondary

MeasureTime frame
overall survival;acute and chronic toxic reactions;

Countries

China

Contacts

Public ContactZhang Yanshan

Wuwei Tumor Hospital Heavy Ion Center

13830510999@163.com+86 138 3051 0999

Outcome results

None listed

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