Phase II clinical study of neoadjuvant immunotherapy combined with chemoradiotherapy in locally advanced unresectable esophageal cancer

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100054327

Enrollment

Unknown

Registered

2021-12-13

Start date

2021-03-23

Completion date

Unknown

Last updated

2022-11-14

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:Neoadjuvant immunotherapy combined with chemoradiotherapy

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-75 years; 2. Pathology or cytology confirmed as T4bN0-3M0 (AJCC 8th TNM stage) esophageal squamous cell carcinoma; 3. Chinese Academy of Medical Sciences receives primary treatment; 4. KPS>=70; 5. Normal organ and bone marrow function, as defined below: (1) Hemoglobin: >=100 g/L, white blood cells: >=3500 G/L, neutrophils: >=1,500 G/L; (2) Platelets: greater than or equal to 100,000/mm^3; (3) Creatinine is within the upper limit of normal, BUN is within the upper limit of normal, AST/ALT: <= 1.5 times the upper limit; (4) Total bilirubin: <=1.5 times the upper limit, alkaline phosphatase: less than or equal to 1.5 times the upper limit; 6. Informed consent.

Exclusion criteria

Exclusion criteria: 1. Those with a history of cervical cancer in situ and other cancers within 5 years; 2. Non-malignant melanoma skin cancer; 3. Have undergone any chemotherapy or other cancer treatment prior to this agreement; 4. Any distant metastasis in liver, lung, bone, central nervous system or peritoneal transplantation; 5. There is a history of contrast agents, similar chemicals or - allergic reactions; 6. The presence of esophageal fistula, perforation and cachexia; 7. Existing active infections, such as active tuberculosis and hepatitis; 8. Uncontrolled disease, including but not limited to infection, symptomatic heart failure, unstable angina, arrhythmia or mental illness; 9. History of myocardial infarction or ventricular arrhythmia within the past 6 months; 10. Participate in other clinical trials at present or within 4 weeks; 11. Patients who are pregnant or breastfeeding.

Design outcomes

Primary

Measure	Time frame
1-year progression-free survival;	—

Secondary

Measure	Time frame
R0 resection rate;Pathological response rate;Postoperative complications;Acute side effects of the protocol;Locoregional recurrence free survival;Overall survival;Association of PD-L1 expression with effecacy of the regimen;	—

Countries

China

Contacts

Public ContactLi Yin

National Cancer Center/Peking Union Medical College Cancer Hospital, Chinese Academy of Medical Sciences

liyin_thorax@163.com+86 13903838752

Outcome results

None listed

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