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Clinical study of neoadjuvant immunity combined with radiotherapy and chemotherapy in the treatment of thoracic esophageal squamous cell carcinoma

Clinical study of neoadjuvant immunity combined with radiotherapy and chemotherapy in the treatment of thoracic esophageal squamous cell carcinoma

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100046931
Enrollment
Unknown
Registered
2021-05-31
Start date
2021-07-01
Completion date
Unknown
Last updated
2022-01-10

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

Conditions

Esophageal cancer

Interventions

Sponsors

Air Force Specialty Medical Center, PLA
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Malignant tumors of the thoracic esophagus confirmed by pathology as squamous cell carcinoma. 2. The clinical stage before treatment is locally advanced (T3-4aN0-1M0) or local early with regional lymph node metastasis (T1-2N1M0). 3. The expected survival time is greater than 6 months. 4. Aged 18-65 years, with a KPS score> 80 (see Annex 1 for the KPS scoring standard). 5. Laboratory test indicators must meet the following requirements: Blood routine: white blood cell >=4.0x10^9/L, neutrophil >=1.5x10^9/L, platelet count >=100x10^9/L, hemoglobin >=90g/L; Liver and kidney function: serum bilirubin is lower than 1.5 times the maximum normal value, ALT and AST are lower than 1.5 times the maximum normal value, BUN and Cr are within the normal range. 6. The patient has not received formal anti-tumor therapy in the past. 7. Able to understand the situation of this research and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. There are high risk factors for esophageal perforation. 2. Anti-tumor therapy (including chemotherapy, radiotherapy, and surgery) has been performed. 3. Those who are known or suspected to be allergic to chemotherapy drugs such as paclitaxel and lobaplatin. 4. Presence or coexistence of bleeding disorders. 5. Other uncontrollable and inoperable patients. 6. Patients during pregnancy and lactation. 7. Due to previous operations, the gastroesophagus can not be used to reconstruct the digestive tract in this operation. 8. Patients with peripheral neuropathy, CTC grade >= 2. 9. Patients with a history of malignant tumors other than esophageal cancer before enrollment, except for non-melanoma skin cancer and cervical cancer in situ. 10. The researcher thinks it is inappropriate to participate in this research. 11. Patients with severe heart, lung, liver, kidney insufficiency, hematopoietic system diseases, immune system diseases, cachexia and other intolerable surgery.

Design outcomes

Primary

MeasureTime frame
2-year progression-free survival rate;1, 2 year survival rate;Objective remission rate;Toxic and side effects;Adverse Events;

Countries

China

Contacts

Public ContactYan Maohui

Air Force Specialty Medical Center, PLA

yanmaohui1984@sina.com+86 18301071600

Outcome results

None listed

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