CLINICAL TRIAL

Yttrium-90 RadioEmbolization for Neoplasm Metastasis

Metastatic
Recruiting · 18+ · All Sexes · Iowa City, IA

This study is evaluating whether a combination of immunotherapy and radiation therapy may be effective for individuals with liver-predominant colorectal cancer.

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About the trial for Neoplasm Metastasis

Eligible Conditions
Neoplasm Metastasis · Liver Neoplasms · Neoplasms, Second Primary · Rectal Neoplasms · Rectal Carcinoma · Metastatic Colorectal Cancer (CRC) · Liver Metastasis Colon Cancer · Colorectal Adenocarcinoma (CRC) · Colorectal Carcinoma (CRC) · Colorectal Neoplasms · Hepatic Metastases · Malignant Neoplasm of Colon · Colonic Neoplasms

Treatment Groups

This trial involves 2 different treatments. Yttrium-90 RadioEmbolization is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Yttrium-90 RadioEmbolization
RADIATION
Durvalumab
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Durvalumab
FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Must have liver metastases and be appropriate for treatment with Y-90 radioembolization therapy as determined by the treating medical oncologist and interventional radiologist/oncologist, and nuclear medicine physician(s). NOTE: the goal of therapy is safety and parenchymal sparing. Typically, since the treatment is personalized, the goal is to have at least 30% liver parenchymal sparing post treatment.
At least 2 but no more than 3 lines of therapy allowed in metastatic setting. These include at least treatment with a fluoropyrimidine, oxaliplatin, and/or irinotecan-based therapy, an anti-VEGF therapy and, if RAS wild-type, an anti-EGFR therapy, unless deemed intolerant or not suitable by the treating oncologist. NOTE: adjuvant and/or maintenance chemotherapy does not count as an additional line of therapy. (Patients with more than 3 lines of therapy are at risk for liver disease from prior systemic therapies and would not be reasonable candidates for Y90-RE).
Negative serum pregnancy test done ≤7 days prior to registration, for persons of childbearing potential only.
Females of childbearing potential (FOCBP), must use appropriate method(s) of contraception. FOCBP are defined as those who are not surgically sterile (i.e., bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or postmenopausal (defined as 12 months with no menses without an alternative medical cause). Additionally, FOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with durvalumab plus 5 half-lives of durvalumab (13 weeks) plus 30 days (duration of ovulatory cycle) for a total of 17 weeks post-treatment completion (details in appendix).
Men who are sexually active with FOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with durvalumab plus 5 half-lives of durvalumab plus 90 days (duration of sperm turnover) for a total of 25 weeks post-treatment completion (details in appendix).
Age ≥18 years
Histological or cytological confirmation of colorectal cancer with metastasis to the liver. Mismatch repair or microsatellite instability status of the tumor needs to be known. Tumors need to be mismatch repair proficient (for mismatch repair deficient tumors immunotherapy is already approved).
Patient must have at least 1 liver lesion measurable as defined in the protocol
Must have a metastatic focus amendable to biopsy. It is permissible to use same or alternative lesion for biopsy for assessment for tumor response and changes in microenvironment (mandatory pre- and post-Y90-RE biopsy).
ECOG Performance Status (PS) 0 or 1.
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Up to 2 years
Screening: ~3 weeks
Treatment: Varies
Reporting: Up to 2 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to 2 years.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Yttrium-90 RadioEmbolization will improve 1 primary outcome, 7 secondary outcomes, and 5 other outcomes in patients with Neoplasm Metastasis. Measurement will happen over the course of Initiation of treatment up to 8 weeks and 2 doses ("priming") of immunotherapy prior to Y90-RE..

Determine the maximum tolerated dose (MTD) of Yttrium-90 radioembolization combined with immunotherapy durvalumab to treat liver-predominant metastatic colorectal cancer (mCRC)
INITIATION OF TREATMENT UP TO 8 WEEKS AND 2 DOSES ("PRIMING") OF IMMUNOTHERAPY PRIOR TO Y90-RE.
MTD will be defined as the highest dose level for which at most 1 out of 6 patients experience a dose-limiting toxicity (DLT) using CTCAE version 5.0.
INITIATION OF TREATMENT UP TO 8 WEEKS AND 2 DOSES ("PRIMING") OF IMMUNOTHERAPY PRIOR TO Y90-RE.
Determine the disease control rate (DCR)
UP TO 2 MONTHS POST TREATMENT
Disease control rate is defined as the proportion of evaluable patients that have achieved a complete response (CR), partial response (PR), or stable disease (SD) by RECIST v1.1 as well as mRECIST and iRECIST.
UP TO 2 MONTHS POST TREATMENT
Determine overall response rate (ORR)
UP TO 2 MONTHS POST TREATMENT
Overall response rate is defined as the proportion of evaluable patients that have achieved a complete response (CR) or partial response (PR) by RECIST v1.1 as well as mRECIST and iRECIST.
UP TO 2 MONTHS POST TREATMENT
Immune correlates - tissue
UP TO 2 MONTHS POST TREATMENT
To assess the changes in immune infiltration (TISSUE: tumor-infiltrating lymphocytes - TILs (CD-3, CD-8), PD-L1 and PD-1 expression, pre- and post-Y90-RE and immunotherapy)
UP TO 2 MONTHS POST TREATMENT
Immune correlates - blood
UP TO 2 MONTHS POST TREATMENT
To analyze serial changes in immune cells (BLOOD) pre- and post-Y90-RE and immunotherapy
UP TO 2 MONTHS POST TREATMENT
Abscopal effects
UP TO 2 MONTHS POST TREATMENT
To report on any abscopal effects seen in terms of responses outside the Y90-RE field
UP TO 2 MONTHS POST TREATMENT
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is rectal carcinoma?

In most Western societies rectal carcinoma is uncommon. However, as the number of surgeries performed on men with prostate cancer increases, in turn the number of men, particularly older men, will present with rectal cancer. Rectal carcinoma is usually a late manifestation of a more aggressive disease but it is also relatively radioresistant and so may be treated by the same curative modalities used to treat prostate cancer.

Anonymous Patient Answer

How many people get rectal carcinoma a year in the United States?

Approximately 14% of patients with stage III or IV rectal carcinoma die per year. This information will be useful at time of diagnosis when the doctor and the patient decide on options, including surgery, chemo- and radiation therapy, and palliative care. Survival seems to be similar across histopathologic differentiation of rectal carcinoma in the United States.

Anonymous Patient Answer

What are common treatments for rectal carcinoma?

Rectal carcinomas may be treated with surgical resection alone. If the tumor infiltrates the margins of the surgical resection specimen, additional treatment with radiotherapy may be recommended. For tumors with positive nodes, systemic chemotherapy may be considered.

Anonymous Patient Answer

What are the signs of rectal carcinoma?

Rectal bleeding, a painful or bleeding stool, an unintentional weight loss, or rectosigmoid colon cancer that has spread may warrant consideration for pre-operative imaging. In a recent study, findings may be signs of an unresectable tumor. Lateral rectal cancer is associated with a higher percentage of lymph node involvement and lymph node involvement of distant metastases, a poor prognosis and would be considered an indication to perform a total mesorectal excision (TME). On CT scan, the most specific abnormality is a well-defined solid mass that does not have a shadow effect around it.

Anonymous Patient Answer

What causes rectal carcinoma?

Results from a recent paper indicates that trauma, particularly from childhood, is an important etiological factor. More specifically, trauma after anorectal surgery is an important risk factor. The lack of correlation with colonic polyploidy may be a result of the relatively low prevalence of rectal cancer in our population of patients with polyploidy.

Anonymous Patient Answer

Can rectal carcinoma be cured?

Rectal cancer cannot be cured. However, the stage of the cancer determines the outcome. The 5-year survival rate for T1 and T2 cancers is high with proper treatment; however, in advanced T3 tumors the 5-year survival rate is only 40%, which has led to the inclusion of concurrent chemotherapy with radiation therapy with curative intent in the treatment protocol. The use of modern chemotherapy combined with radiation therapy has increased the five-year survival rate from 40% to 85-90%. The 5-year survival rate increases to 100% when combined with careful, pre-operative, surgical staging and adequate post-operative radiotherapy.

Anonymous Patient Answer

Have there been other clinical trials involving yttrium-90 radioembolization?

We believe that the use of yttrium-90 radioembolization may be a safe procedure that could lead to better outcomes in patients with unresectable liver or extrapalna cancer. However, more complete data need to be obtained on this interesting treatment.

Anonymous Patient Answer

What is the primary cause of rectal carcinoma?

Results from a recent clinical trial suggest that the most common risk factor for rectal carcinoma is chronic inflammation induced by a persistent infection with a bacteria known to cause chronic rectal disease. These studies suggest that screening for chronic rectal disease may decrease the incidence and the death rate from rectal carcinoma.

Anonymous Patient Answer

Have there been any new discoveries for treating rectal carcinoma?

The new drugs being explored are likely to be successful, as many are already approved for breast carcinoma. Further study should be on the potential of other treatment modalities that have not yet been tested in rectal cancer.

Anonymous Patient Answer

What are the latest developments in yttrium-90 radioembolization for therapeutic use?

As a non-invasive intervention, [(90)Y] RIT is effective in controlling cancer load but must be assessed in clinical trials using standardized protocols to prove its safety and effectivity as a monotherapy or in combination with systemic therapy.

Anonymous Patient Answer

What are the common side effects of yttrium-90 radioembolization?

A common adverse effect following treatment with Y90-based radioembolic therapy is transient bowel or bladder spasm, which can be a significant problem in patients with severe comorbidities, even if the procedure can be performed on an outpatient basis. In our experience, post-treatment computed tomographic imaging should be performed in all such patients as soon as practical after treatment to prevent bowel wall spasm and other complications.

Anonymous Patient Answer

Who should consider clinical trials for rectal carcinoma?

The current study may help guide oncologists and patients to understand the risks and the benefits of clinical trials to help with the decision-making process. For those [with a stageT3N0M0(0) or T3N0M0(+) tumour pattern] and/or a high BMI (> or =25), the inclusion in a clinical trial may not be necessary.

Anonymous Patient Answer
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