CT-Guided Adaptive Radiation Therapy Combine With Anti-PD-1 Antibody Adjuvant Immunotherapy for Thoracic Cancer Patients

• Status: Recruiting
• Trial end date: 2022-05-31
• Target enrollment: 0
• Participant gender: All

Summary

This phase II study is to evaluate the safety and efficacy of CT-based adaptive radiation therapy followed by adjuvant anti-PD-1 antibody immunotherapy in treating patients with different types and stages of thoracic malignancies. (CARTAI)

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Taizhou Hospital
• Treatments: Antibodies; Immunoglobulins

Criteria

Inclusion Criteria:

1. Signed inform consent form

2. Age >= 18 years and <= 75 years

3. Histologically or cytologically confirmed advanced/metastatic thoracic malignancies

4. Patients must receive adaptive radiation therapy within 45 days before the first dose of trial treatment

5. Eastern Cooperative Oncology Group performance status of 0 or 1

6. Life expectancy >= 8 weeks

7. Adequate hematologic and end organ function

Exclusion Criteria:

1. Prior exposure to any immune checkpoint inhibitors including but not limited to anti-PD-1, anti-PD-L1 or anti-CTLA-4 antibodies.

2. Prior exposure to any other thoracic radiation therapy before this time radiation therapy.

3. Prior exposure to steroid therapy or any other form of immunosuppressive therapy within 14 days before the first dose of trial treatment

4. No active second cancers

5. Active or prior autoimmune disease or immunodeficiency.

6. Active infections including but not limited to hepatitis B, C ,and HIV.

7. Significant cardiovascular disease

8. Active or untreated central nervous system (CNS) metastases

9. Any unresolved toxicity CTCAE >= Grade 3 from the prior radiation therapy.

10. Known hypersensitivity to humanized antibodies or fusion proteins or any of study drug excipients.

11. Known psychiatric or physical impairments that would interfere with cooperation with the protocol of this trial.