Can a Two-Drug chemo combo outsmart resistant tumors?
NCT ID NCT07782346
First seen Aug 24, 2026 · Last updated Aug 27, 2026 · Updated 3 times
Summary
This early-stage trial is testing whether combining two chemotherapy drugs—liposomal irinotecan and cisplatin—can safely shrink or control advanced solid tumors that have not responded to standard treatments. The study will enroll about 44 adults aged 20 to 85 with various types of advanced cancer. The main goal is to find the safest and most effective dose of the drug combination, while also checking how well it works against the tumors.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- A combination of two chemotherapy drugs: liposomal irinotecan (Nal-IRI) and cisplatin, given intravenously.
- What this could lead to
- If this combination proves safe and effective, it could offer a new treatment option for people with advanced solid tumors that have stopped responding to standard therapies.
- What could go wrong
- This is an early-phase trial, so the main goals are to find the right dose and check safety. The combination may not work for all tumor types, and chemotherapy can cause significant side effects.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 44 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2032
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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20 to 85 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 1\. Patients with age 20-85 years old. * 2\. Cytologically or histologically confirmed solid malignancies which are locally advanced, recurrent or metastatic diseases. The disease cannot be cured by surgical intervention or local therapies. * 3\. The malignancies are refractory to standard systemic therapy or there is no available systemic therapy. * 4\. Followings are the diseases entities which are limited in each part: * a. Dose escalation phase (cohort 1): non-small cell lung cancer, small cell lung cancer, gastric cancer, neuroendocrine carcinoma, biliary tract cancer (including intrahepatic cholangiocarcinoma \[CCA\], extrahepatic CCA, gallbladder cancer, ampullary cancer), ovarian cancer, esophageal cancer, thymoma or thymic carcinoma. * b. Dose expansion phase (cohort 2): only thymic carcinoma. * 5\. Radiologically measurable disease as defined by RECIST v1.1. * 6\. Baseline ECOG performance status score 0-1. * 7\. Life expectancy of at least 12 weeks. * 8\. Adequate hematologic parameters, and hepatic and renal functions defined as * a. Absolute neutrophil count ≥ 1500 /μL (without growth factor support at least 7 days). * b. Platelets ≥ 90000 /μL (evaluated at least 7 days after last platelet transfusion). * c. Hemoglobin ≥ 9 g/dL (evaluated at least 14 days after last RBC transfusion). * d. Total bilirubin ≤ 1.5X ULN. * e. AST/ALT ≤ 2.5X ULN (≤ 5X ULN if attributable to liver metastases). * f. serum creatinine ≤ 1.5 x ULN or creatinine clearance rate (CCr) ≥ 50 mL/min (calculated by Cockcroft-Gault formula \[CCr={((140-age) x weight \[kg\])/(72x serum creatinine \[mg/dL\])}x 0.85 (if female)\] or 24-hour urine collection). * 9\. Normal ECG or ECG without any clinical significant findings. * 10\. Able to understand and sign an informed consent (or have a legal representative who is able to do so). * 11\. Women or men of reproductive potential should agree to use an effective contraceptive method. Exclusion Criteria: * 1\. Patients who have major surgery, radiotherapy or other systemic chemotherapy or immunotherapy within 3 weeks are not eligible. Patients who have palliative radiotherapy will be eligible if the irradiated area does not involve the only lesion of measurable / evaluable disease. * 2\. Patient with history of severe allergy to liposomal irinotecan (nal-IRI; ONIVYDE®) or cisplatin. * 3\. Significant cardiovascular impairment: (1) history of congestive heart failure greater than New York Heart Association (NYHA) Class II, left ventricular ejection fraction\< 50%; or (2) unstable angina, myocardial infarction or stroke within 6 months; or (3) uncontrolled cardiac arrhythmia. * 4\. Patients with electrolyte abnormalities that have not been corrected. * 5\. Patients with active metastatic lesions in central nervous system, or need prednisolone ≥ 10 mg/day to control related symptoms * 6\. Patients with active bacterial, fungal, tuberculosis or human immunodeficiency virus infection * 7\. Patients with positive hepatitis B surface antigen (HBsAg) but not receiving anti-hepatitis B drug. Patients who have positive HBsAg, positive anti-HBc, or positive anti-HCV are eligible if the corresponding HBV-DNA or HCV-RNA are undetectable. * 8\. Subjects who have not recovered adequately from any toxicity from other anti-cancer treatment regimens and/or complications from major surgery prior to starting therapy. * 9\. Patients who have peripheral neuropathy \> grade I of any etiology. * 10\. Patients who have serious concomitant systemic disorders incompatible with the study, i.e. poorly controlled diabetes mellitus, auto-immune disorders, or other condition that in the opinion of the investigator would preclude the subject's participation in the study. * 11\. Patients who have other prior or concurrent malignancy except for adequately treated in situ carcinoma or basal cell carcinoma of skin, or any malignancy which remains disease-free for 3 or more years after curative treatment. * 12\. Females who are breastfeeding or pregnant at screening or baseline. * 13\. Patients with psychiatric illness which would preclude study compliance. * 13\. Patients with psychiatric illness which would preclude study compliance. * 14\. Patients who have received any prior treatment with ONIVYDE® (liposomal irinotecan) or irinotecan-containing regimens
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
6 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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China Medical University Hospital
Taichung, Taiwan
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MacKay Memorial Hospital
Taipei, Taiwan
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National Cheng Kung University Hospital
Tainan, Taiwan
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National Taiwan University Hospital
Taipei, Taiwan
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Taichung Veterans General Hospital
Taichung, Taiwan
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Taipei Veterans General Hospital
Taipei, Taiwan
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- Operationalising multifactorial ovarian cancer risk assessment using the CanRisk tool versus standard practices.
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