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The efficacy evaluation and mechanism analysis of radiotherapy combined with immunotherapy in neoadjuvant treatment of esophageal cancer patients

The efficacy evaluation and mechanism analysis of radiotherapy combined with immunotherapy in neoadjuvant treatment of esophageal cancer patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000035428
Enrollment
Unknown
Registered
2020-08-10
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-08-17

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

Conditions

Esophageal cancer

Interventions

Group 1:Radiotherapy
Group 2:Radiotherapy + PD-1 Monoclonal antibody
Group 3:Radiotherapy + PD-1 Monoclonal antibody + CIK

Sponsors

Shanghai Huadong Hospital/Huadong Hospital affiliated to Fudan university
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1. Diagnosis of patients with esophageal cancer; 2. Patients with clinical TNM stage III-IV; 3. Aged 18 to 75 years old; 4. Eastern Cooperative Oncology Group (ECOG) score 0-2 (see ECOGO scores in Annex I); 5. The main organs function well and the coagulation function is normal; 6. Life expectancy >=3 months; 7. Subjects signed an informed consent form prior to enrollment and agreed to participate in the study and follow the research procedure.

Exclusion criteria

Exclusion criteria: 1. Uncontrolled puncture site infection or systemic infection; 2. uncontrollable systemic bleeding disorders, severe hypercoagulable state, severe coagulopathy or subjects are using drugs that affect coagulation; 3. Those with a history of deep vein thrombosis or a history of pulmonary embolism; 4. Severe comorbidities, such as grade III, grade IV (New York Heart Association NYHA standard), myocardial infarction within 6 months or grade 3 or higher (including grade 3) angina pectoris, brain trauma, brain parasitism Patients with worm disease, progressive stroke, hepatic encephalopathy, autoimmune hepatitis, decompensated cirrhosis, liver dysfunction, renal insufficiency; 5. A history of allergic reactions to antibody drugs, or allergic patients, or those who are allergic to the test needle; 6. Human immunodeficiency virus (HIV)-positive patients, immunodeficiency diseases, combined immunodeficiency diseases, organ transplants, and patients with autoimmune diseases requiring immunosuppressive or steroidal therapy; 7. Previous history of other malignant tumors, except for cured skin basal cell carcinoma or squamous cell carcinoma, cervical carcinoma in situ; 8. pregnant or lactating women; 9. According to the judgment of the investigator, there are serious accompanying diseases (including but not limited to hypertension, severe diabetes, active infection, thyroid disease, etc.) that seriously endanger the safety of the patient or affect the patient's completion of the study; 10. Any mental or cognitive impairment, emotionally unstable, may limit its understanding of the informed consent, implementation, and compliance with the study; 11. The investigator believes that it is not suitable for other situations in this trial.

Design outcomes

Primary

MeasureTime frame
lymphocyte subsets;pathological remission rate;tumors ''neoantigen'';

Countries

China

Contacts

Public ContactWen Gao

Shanghai Huadong Hospital/Huadong Hospital affiliated to Fudan university

gaowenchest@163.com+86 18918888502

Outcome results

None listed

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