Can a Two-Drug chemo combo outsmart resistant tumors?

NCT ID NCT07782346

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 44 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Dec 2032

An estimate. End dates often move.

Lead sponsor

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

20 to 85 years

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    6 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • China Medical University Hospital

    Taichung, Taiwan

  • MacKay Memorial Hospital

    Taipei, Taiwan

  • National Cheng Kung University Hospital

    Tainan, Taiwan

  • National Taiwan University Hospital

    Taipei, Taiwan

  • Taichung Veterans General Hospital

    Taichung, Taiwan

  • Taipei Veterans General Hospital

    Taipei, Taiwan

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