Clinical trial · Interventional
Cyclophosphamide, Radiation Therapy, and Poly ICLC in Treating Patients With Unresectable, Recurrent, Primary, or Metastatic Liver Cancer
Phase I/II Study of Autologous Tumor Cell Vaccination Using Metronomic Cyclophosphamide, 3-Dimensional Conformal Radiotherapy, Intra/Peri-Tumor Injection of Poly ICLC With Trans-Hepatic Arterial Embolization Followed by Poly ICLC Boosting in Patients With Unresectable, Recurrent, or Metastatic Cancers in the Liver (Hepatoma, Cholangiocarcinoma, Neuroendocrine, Breast, Colon, Gastric, and Esophageal Cancer)
- 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)
RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Poly ICLC may stop the growth of liver cancer by blocking blood flow to the tumor. Giving the drug directly into the arteries around the tumor may kill more tumor cells. Giving cyclophosphamide and radiation therapy together with poly ICLC may be an effective treatment for liver cancer. PURPOSE: This phase I/II trial is studying the side effects of giving cyclophosphamide, radiation therapy, and poly ICLC together and to see how well they work in treating patients with unresectable, recurrent, primary, or metastatic liver cancer.
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
| Melanoma (Skin) | Melanoma | ONTOLOGY_EXACT | 0.85 |
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 3-dimensional conformal radiation therapy | Radiation | — | UNRESOLVED |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| hepatic artery embolization | Procedure | — | UNRESOLVED |
| poly ICLC | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- poly ICLC
- interventionNames
- Drug: cyclophosphamide
- Drug: poly ICLC
- Procedure: hepatic artery embolization
- Radiation: 3-dimensional conformal radiation therapy
Primary outcomes (1)
- measure
- Overall tolerability
- timeFrame
- up to 90 days
Secondary outcomes (2)
- measure
- Progression-free survival at 6, 12, and 24 months
- timeFrame
- up to 24 months
- measure
- Overall survival at 6, 12, and 24 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Radiologically or histologically confirmed hepatocellular carcinoma
* Stage III or IV primary disease
* Recurrent, unresectable, or metastatic disease meeting any of the following criteria:
* Pancreatic cancer that underwent prior surgical resection and progressed with recurrent metastatic disease to the liver
* Gastric, colon, breast, or ovarian cancer or melanoma with metastatic disease to the liver
* Primary or recurrent disease that cannot be surgically resected leaving the patient disease-free
* Radiologically measurable disease
* Ineligible for liver transplantation according to University of San Francisco listing criteria:
* Single lesion \> 6.5 cm
* Three or more tumors \> 4.5 cm
* Cumulative tumor diameter \> 8 cm
PATIENT CHARACTERISTICS:
* Karnofsky performance status 60-100%
* ANC ≥ 1,500/mm³
* Platelets ≥ 75,000/mm³
* Creatinine ≤ 1.7 mg/dL
* Total bilirubin ≤ 1.5 mg/dL
* AST and ALT ≤ 3 times the upper limit of normal
* INR \< 1.5
* LVEF ≥ 50%
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No serious concurrent infection or medical illness that would render the protocol treatment unsafe
* LVEF ≥ 50%
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No concurrent steroidsReferences
Publications (0)
Data not yet available