Clinical trial · Interventional
A Pilot Study of Radiation-Immune Cell Combination Therapy in Cervical Cancer
A Pilot Study of Radiation-Immune Cell Combination Therapy in Recurrent or Persistent Cervical Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): No further enrollment after two patients
Summary
Brief summary (as posted)
Among the immune cell therapy, autologous adoptive immune cell therapy is a method to transfer the immune cells derived from peripheral white blood cells and expanded and stimulated with various cytokines and tumor specific antigens in cancer patients. Recently, the low-dose radiation is known to increase the immune response in many human cancer patients. In a clinical trial, 70% response rate with combination of low-dose radiation and adoptive immune cell therapy was reported in recurrent melanoma patients. This study is to investigate the feasibility of combination of low-dose radiation and autologous immune cell therapy in recurrent cervical cancer which is resistant to conventional palliative treatment.
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 |
|---|---|---|---|
| Uterine Cervical Neoplasms | Cervical Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Immune cell | Biological | — | UNRESOLVED |
| Low dose radiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Low dose radiation, Immune cell therapy
- description
- Combination treatment of low-dose radiation 20cGy every 3 weeks three times and autologous immune cell therapy 2 consecutive weeks 3 times every 3 weeks
- interventionNames
- Biological: Immune cell
- Radiation: Low dose radiation
Primary outcomes (1)
- measure
- Response rate
- timeFrame
- 12months
- description
- Response rate according to RECIST criteria for 12 months
Secondary outcomes (1)
- measure
- Toxicity
- timeFrame
- 12months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients must have signed an approved informed consent and authorization permitting release of personal health information. 2. Age 18-75 years 3. Pathologically proven recurrent or persistent cervical cancer patients resistant to conventional palliative chemotherapy or radiation therapy 1. Persistent tumor more than 1cm after initial chemoradiation or radiation therapy 2. Persistent tumor more than 1cm after chemoradiation, radiation or chemotherapy in recurrent cervical cancer 3. Metastatic cervical cancer to lung resistant to conventional chemotherapy 4. ECOG performance status 0, 1, 2. 5. Expected survival more than 3 months 6. Patients must have adequate: Hematologic function: ANC ≥ 1,500/mcl, Hemoglobin \>10g/dL, platelets ≥ 100,000/mcl Renal function: creatinine ≤ 1.5 x ULN Hepatic function: AST, ALT ≤ 1.5 x ULN, 7. More than 3 weeks from the last day of previous chemotherapy or radiation Exclusion Criteria: 1. Patients with immune disease or auto-immune disease (ex. rheumatoid arthritis, SLE, immune vasculitis, IDDM) 2. Immune deficiency disease 3. Cancers other than cervical cancer within 5 years 4. Acute myocardial infarction, uncontrolled hypertension 5. Severe allergic disease 6. Severe psychotic disease 7. Those who can be a candidate for curative surgery
References
Publications (0)
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