Radiotherapy in Combination With TTI-101 in Borderline Resectable and Locally Advanced Pancreatic… (NCT06141031) | Clinical Trial Compass
RecruitingPhase 1
Radiotherapy in Combination With TTI-101 in Borderline Resectable and Locally Advanced Pancreatic Ductal Adenocarcinoma
United States18 participantsStarted 2024-01-16
Plain-language summary
The survival rate for patients with pancreatic cancer remains at a dismal 10% or less at 5 years, and although trials integrating stereotactic body radiation therapy (SBRT) alone have shown improvement in local control, initial invigoration of immune response, and relief of symptom burden, SBRT has not demonstrated any improvement in survival. Preclinical research has established that STAT3 inhibition given concurrently with SBRT and in the maintenance phase acts as a synergistic agent that enhances the pro-inflammatory effects of SBRT while reducing its undesired effects (including fibrosis and immunosuppression). This study exploits the window of opportunity post-chemotherapy to advance the hypothesis that the addition of STAT3 inhibition in combination with SBRT will be safe and will enhance 2-year progression-free survival.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Pathologically confirmed pancreatic adenocarcinoma that is borderline resectable or locally advanced as defined by NCCN guidelines, with no expected arterial resection/reconstruction.
* Patients who are borderline resectable must have completed standard of care induction chemotherapy between 1 and 3 weeks prior to planned start of TTI-101 + SBRT. Patients who exceed this window may be considered for enrollment if they complete an additional cycle of induction chemotherapy prior to initiation of study treatment (per provider discretion). The amount of induction chemotherapy cycles allowed will be left to the discretion of the treating medical oncologist. There is no timing restriction for patients with locally advanced disease.
* At least 18 years of age.
* ECOG performance status ≤ 2
* Adequate bone marrow and organ function as defined below:
* Absolute neutrophil count ≥ 1.0 K/cumm
* Platelets ≥ 70 K/cumm
* Hemoglobin ≥ 9.0 g/dL (patients may be transfused to meet this criterion)
* Total bilirubin ≤ 2 mg/dL
* AST(SGOT)/ALT(SGPT) ≤ 3.0 x IULN
* Serum albumin ≥ 2.8 g/dL
* Ionized calcium ≤ 1.5 mmol/L, calcium ≤ 12 mg/dL, or corrected serum calcium ≤ IULN)
* Measured creatinine clearance \> 40 mL/min or calculated creatinine clearance \> 40 mL/min by Cockcroft-Gault or by 24-hour urine collection for determination of creatinine clearance (calculations in protocol).
* Able to swallow pills.
* INR and aPTT ≤ 1.5 x IULN unless patient is rec…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D) of TTI-101 and SBRT
Timeframe: Through completion of follow-up (estimated to be 2 years and 3 months)