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Randomized controlled Phase 3 clinical study involving IMRT combined with Tiggio or TC regimen in elderly patients with esophageal squamous cell carcinoma

Randomized controlled Phase 3 clinical study involving IMRT combined with Tiggio or TC regimen in elderly patients with esophageal squamous cell carcinoma

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500095263
Enrollment
Unknown
Registered
2025-01-03
Start date
2023-09-05
Completion date
Unknown
Last updated
2025-01-06

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

Conditions

Esophagus cancer

Interventions

Experimental group:Patients in the experimental group will undergo radical concurrent radiochemotherapy, with a total radiation dose of 50.4Gy/28Fx for the primary esophageal lesion and related metast
Control group:Patients in the control group will receive radical concurrent chemoradiotherapy, with a total radiotherapy dose of 50.4 Gy delivered in 28 fractions targeting the primary esophageal lesi

Sponsors

Jiangsu Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
70 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Sign the informed consent form; 2. Age>=70 years; 3. Histologically confirmed esophageal squamous cell carcinoma, naïve treatment (no surgery/radiotherapy/chemotherapy and targeted therapy); 4. Elderly patients with esophageal squamous cell carcinoma who are inoperable, unwilling to undergo surgery, and willing to undergo radiotherapy; cII-IVa (UICC 8th, including stage IV.b of supraclavicular lymph node metastases, excluding stage IV.b of other distant metastases) 5. No serious hematopoietic function, abnormal heart, lung, liver, kidney function and immune deficiency; 6. Normal organ and bone marrow function, defined as follows: white blood cell count >=4,000/µL, hemoglobin >=9 g/dL (without blood transfusion), neutrophil count >=2,100/µL, platelet count >=100, 000/µL, total bilirubin 3 months; 10. There is no primary tumor in other parts before treatment, or there is a primary tumor in other parts but has been controlled for more than 5 years.

Exclusion criteria

Exclusion criteria: 1. Esophageal perforation or hematemesis; 2. Secondary primary tumors (except cured non-malignant melanoma of the skin, thyroid papillary carcinoma, spermatogonial carcinoma stage I, cervical carcinoma in situ or other "curable" tumors that survive for more than 3 years after treatment); 3. Used other investigational drugs or participated in other clinical trials in the 30 days prior to randomization; 4. Drug addiction, long-term alcoholism, and AIDS patients; 5. Myocardial infarction time Patients who need myocardial thallium angiography at 6 months to show no myocardial ischemia and whose cardiologist agrees chemotherapy can be included in the study. 6. Uncontrollable seizures, or loss of self-awareness due to mental illness; 7. People with a history of severe allergies or specific constitutions; 8. Researchers consider it inappropriate to participate in this experiment; 9. Received radiation therapy in the intended radiotherapy area.

Design outcomes

Primary

MeasureTime frame
Median Survival;

Secondary

MeasureTime frame
Progression-free Survival;Overall Survival;Safety;

Countries

China

Contacts

Public ContactYe Jinjun, Zhou Guoren

Jiangsu Cancer Hospital

jjye2004@163.com+86 139 5168 2839

Outcome results

None listed

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