Clinical trial · Interventional
125I Seed Brachytherapy Combined With Immunotherapy for Primary, Recurrent, or Metastatic Malignant Tumors
A Prospective, Randomized, Open-Label, Parallel-Group Clinical Trial Evaluating the Efficacy and Safety of 125I Seed Interstitial Brachytherapy Combined With Immune Checkpoint Inhibitor Therapy in Patients With Primary, Recurrent, or Metastatic Malignant Tumors Compared With Immune Checkpoint Inhibitor Therapy Alone
- 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 prospective randomized trial evaluates the efficacy and safety of combining 125I seed interstitial brachytherapy with immune checkpoint inhibitor therapy in patients with primary, recurrent, or metastatic malignant tumors. Immunotherapy has become an important systemic treatment option, yet many patients experience limited benefit due to low tumor immunogenicity, insufficient T-cell infiltration, and an immunosuppressive tumor microenvironment. 125I seed brachytherapy provides continuous low-dose-rate radiation to the tumor, promoting antigen release, enhancing dendritic cell activation, and potentially converting immunologically "cold" tumors into more responsive "hot" lesions. Integrating localized radiation with systemic immunotherapy may improve tumor response, prolong progression-free survival, and reduce recurrence. Patients will be randomized 1:1 to receive 125I seed implantation plus immunotherapy or immunotherapy alone. The primary endpoints are objective response rate (ORR) and progression-free survival (PFS). Secondary endpoints include failure-free survival (FFS), overall survival (OS), disease control rate (DCR), duration of response (DoR), local control, recurrence rate, adverse events, and quality of life. Exploratory analyses will assess radiomics features, subgroup responses, and different patterns of recurrence. This study aims to determine whether adding 125I seed brachytherapy enhances the clinical benefits of immunotherapy across diverse malignant tumors.
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 |
|---|---|---|---|
| Malignant Tumors | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 125I Seed Implantation | Other | — | UNRESOLVED |
| Immune Checkpoint Inhibitors | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 125I Seed Brachytherapy + Immunotherapy
- description
- Participants in this arm will receive CT-guided 125I seed interstitial brachytherapy, followed by systemic immune checkpoint inhibitor (ICI) therapy administered according to the approved dosing schedule for the selected agent. Seed implantation will be planned and delivered using standardized TPS-based dosimetric protocols, and immunotherapy will continue until progression, unacceptable toxicity, or study completion.
- interventionNames
- Drug: Immune Checkpoint Inhibitors
- Other: 125I Seed Implantation
- type
- ACTIVE_COMPARATOR
- label
- Immunotherapy Alone
- description
- Participants in this arm will receive systemic immune checkpoint inhibitor (ICI) therapy alone, following the same agent, schedule, and supportive care standards used in the experimental arm. No local radiotherapy or seed implantation will be performed. Treatment will continue until disease progression, unacceptable toxicity, or study completion.
- interventionNames
- Drug: Immune Checkpoint Inhibitors
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18 to 80 years. * Histologically or clinically confirmed primary, recurrent, or metastatic malignant tumor. * At least one measurable lesion according to RECIST 1.1 or iRECIST. * Tumor site suitable for 125I seed implantation under CT or PET/CT guidance. * Planned to receive or eligible to receive an immune checkpoint inhibitor (ICI). * ECOG performance status 0-2. * Adequate organ function: ANC ≥ 1.5 × 10⁹/L Platelets ≥ 80 × 10⁹/L Hemoglobin ≥ 90 g/L AST/ALT ≤ 3 × ULN (≤ 5 × ULN for liver metastasis) Creatinine clearance ≥ 50 mL/min * Life expectancy ≥ 3 months. * Ability to understand and sign informed consent. Exclusion Criteria: * Prior I-125 seed implantation at the planned treatment site. * Active uncontrolled infection or systemic inflammatory disease. * Known history of autoimmune disease requiring systemic immunosuppression. * Prior treatment with immune checkpoint inhibitors within the last 4 weeks. * Uncontrolled coagulopathy or contraindication to interventional seed implantation: INR \> 1.5 Platelets \< 50 × 10⁹/L * Tumor location that poses unacceptable procedural risk, including inability to obtain a safe puncture path. * Severe cardiopulmonary dysfunction (e.g., heart failure, unstable arrhythmia, severe COPD). * Pregnancy or breastfeeding. * Known allergy or contraindication to radiopharmaceuticals, contrast agents, or anesthesia agents used during implantation. * Any condition that, in the investigator's judgment, makes the participant unsuitable for the study (e.g., poor compliance, severe psychiatric disorder).
References
Publications (0)
Data not yet available