Clinical trial · Interventional
CT-Guided Adaptive Radiation Therapy Combine With Anti-PD-1 Antibody Adjuvant Immunotherapy for Thoracic Cancer Patients
A Safety and Efficacy Study of CT-Guided Adaptive Radiation Therapy With Anti-PD-1 Antibody Adjuvant Immunotherapy in Patients With Thoracic Cancer (CARTAI)
NCT03732430CI-TRIAL-00035980CARTAIunknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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)
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Thoracic Malignancies | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IBI308 | Drug | Sintilimab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Anti-PD-1 antibody
- description
- IBI308 200mg intravenous drip every three weeks following adaptive radiation therapy.
- interventionNames
- Drug: IBI308
Primary outcomes (1)
- measure
- AEs and SAEs at 6 months
- timeFrame
- 6 months
- description
- Number of participants with adverse events and serious adverse events at 6 months will be measured. \[CTCAE v4.03\]
Secondary outcomes (5)
- measure
- ORR
- timeFrame
- Estimated to be up to 3 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.