AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

โ† Trials
๐Ÿงช

PDS01ADC in Combination With Hepatic Artery Infusion Pump (HAIP) and Systemic Therapy for Subjects With Metastatic Colorectal Cancer, Intrahepatic Cholangiocarcinoma, or Metastatic Adrenocortical Carcinoma

RecruitingPhase 2Ages 18 Years - 120 YearsAllNational Cancer Institute (NCI)
๐Ÿ’ฌ

In plain words

What the trial is, and whether it could suit you

Background: One way to treat liver cancer is to deliver chemotherapy drugs only to the liver (and not to the whole body). Researchers want to see if adding the drug PDS01ADC can improve the treatment. The drug triggers the immune system to fight cancer.\<TAB\> Objective: To see if treatment with HAIPs to deliver liver-directed FUDR and Dexamethasone chemotherapy in combination with PDS01ADC is effective for certain cancers. Eligibility: People aged 18 and older who have cancer of the bile ducts that is only in the liver, or colorectal cancer that has spread to the liver, or cancer of the adrenal glands that has spread to the liver, who are also receiving or planning to receive standard systemic chemotherapy for their disease. Design: Participants will be screened with: Medical history Physical exam Blood tests Pregnancy test (if needed) Tumor biopsy (if needed) Electrocardio

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
* INCLUSION CRITERIA: Inclusion Criteria- All Cohorts * Participants must have a documented diagnosis of one of the following cancers: * Metastatic colorectal cancer (mCRC) * Intrahepatic cholangiocarcinoma (ICC) * Adrenocortical carcinoma (ACC) with liver dominant disease * Participants must have an identified medical oncologist who has recommended and is planning to oversee treatment with one of the following standard chemotherapy regimens (based on disease type) not to begin sooner than 28 days after initiation of study-directed HAIP intervention: * mCRC: FOLFOX or FOLFIRI * ICC: GemOx or FOLFOX * ACC: GemOx * Age \>= 18 years. * Negative serum or urine pregnancy test at screening for individuals of childbearing potential (IOCBP). NOTE: IOCBP is defined as any individual who has experienced menarche and who has not undergone successful surgical sterilization or who is not postmenopausal. IOCBP must have a negative pregnancy test (HCG blood or urine) during screening. * All participants (regardless of childbearing potential) must agree to use highly effective contraception prior to study entry, for the duration of study participation, and for 3 months after completion of study treatment for those able to father a child or 6 months after completion of study treatment for those of child-bearing potential (i.e., IOCBP). Highly effective birth control (failure rate of less than 1%), e.g., intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomized partner and sexual abstinence. Note: The use of condoms by participants who are able to get other individuals pregnant is required unless the partner of childbearing potential is permanently sterile. * Nursing (including breastfeeding) participants must agree to discontinue nursing. * Arterial anatomy on CT angiogram or CT chest, abdomen and pelvis multiphase (i.e., CT C/A/P multiphase) amenable to placement of the HAIP. * Participant must sign the informed consent form to participate in this study. * HIV-positive participants may be considered for this study only if they have an undetectable viral load. * Participants must agree to co-enroll on the Surgical Oncology Program s tissue collection protocol 13C0176, "Tumor, Normal Tissue and Specimens from Patients Undergoing Evaluation or Surgical Resection of Solid Tumors". * Participant's liver metastases must not be amenable to resection/ablation to No Evidence of Disease (NED) in one stage. Inclusion Criteria-Metastatic Colorectal Carcinoma * Participants must have histologically or cytologically confirmed diagnosis of colorectal adenocarcinoma metastatic to the liver (Cohort 1). * Participants must have measurable liver metastatic disease. * Participants must have received 1st line systemic chemotherapy. * ECOG performance status \<= 1. * Participants must have adequate organ and marrow function as defined below: * leukocytes \> 3,000/mcL * absolute neutrophil count \> 1,500/mcL * platelets \> 90,000/mcL * hemoglobin \> 8 g/dL * total bilirubin \< 1.5 X institutional upper limit of normal * AST(SGOT)/ALT(SGPT) \< 2.5 X institutional upper limit of normal * creatinine within normal institutional limits OR eGFR within normal as predicted by the CKD-EPI equation \> 60 mL/min/1.73 m2. Inclusion Criteria-Intrahepatic Cholangiocarcinoma * Participants must have histologically or cytologically confirmed diagnosis of intrahepatic cholangiocarcinoma confined to the liver (Cohort 2). Archival tumor sample may be used but if archival tissue is not available or is not adequate, tissue biopsy will be required. * Clinical or radiographic evidence of metastatic disease to regional (porta hepatis) lymph nodes will be allowed, provided it is amenable to resection. * Participants must have radiographically measurable disease. * Disease must be considered unresectable at the time of preoperative evaluation. * Participants must have received 1st line systemic chemotherapy. * ECOG performance status \<=1. * Participants must have adequate organ and marrow function as defined below: * leukocytes \>= 2,000/ mm\^3 * absolute neutrophil count \> 1,500/mcL * platelets \>= 75,000/ mm\^3 * hemoglobin \> 8 g/dL * total bilirubin \< 1.5 mg/dl * creatinine \<= 1.5 mg/dl Inclusion Criteria-Adrenocortical Carcinoma * Participants must have histologically or cytologically confirmed diagnosis of adrenocortical carcinoma (ACC), also referred to as "adrenocortical cancer". * Participants must have received at least one line of systemic chemotherapy. * Participants must have measurable liver metastatic disease. * ECOG performance status \<= 1. * Participants must have adequate organ and marrow function as defined below: * leukocytes \> 3,000/mcL * absolute neutrophil count \> 1,500/mcL * platelets \> 90,000/mcL * hemoglobin \> 8 g/dL * total bilirubin \< 1.5 X institutional upper limit of normal * AST(SGOT)/ALT(SGPT) \< 3 X institutional upper limit of normal * creatinine \< 2 X institutional upper limit of normal EXCLUSION CRITERIA: Exclusion Criteria- All Cohorts Participants who are receiving any other investigational agents. * Participants who have previously received rIL-12. * Participants with active autoimmune diseases, that might deteriorate when receiving an immunostimulatory agent with the exceptions: * diabetes type I, vitiligo, alopecia, psoriasis, hypo- or hyperthyroid disease not requiring immunosuppressive treatment are eligible; * participants requiring hormone replacement with corticosteroids are eligible if the steroids are administered only for the purpose of hormonal replacement and at doses \<= 10 mg of prednisone or equivalent per day; * administration of steroids for other conditions through a route known to result in a minimal systemic exposure (topical, intranasal, intro-ocular, or inhalation) is eligible. * History of organ transplant, except for transplants that do not require
๐Ÿ’Š

What it tests

  • Dexamethasone
  • PDS01ADC
  • Intera 3000 Hepatic Artery Infusion Pump (HAIP)
  • Floxuridine
๐Ÿ“

Where

1 site
National Institutes of Health Clinical Center
Bethesda, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
๐Ÿ›ก๏ธ

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it โ€” not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use ยท Privacy