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An exploratory phase II investigator-initiated clinical trial to investigate the added benefit of TM5614 to gemcitabine plus nab-paclitaxel therapy (GnP therapy) for unresectable or recurrent pancreatic cancer with distant metastases.

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Unresectable pancreatic cancer or recurrent pancreatic cancer with distant metastases
Date of first enrollment	12/05/2026
Target sample size	50
Countries of recruitment
Study type	Interventional
Intervention(s)	The investigational drug will be administered orally for a maximum of 48 weeks, starting at 120 mg once daily in combination with gemcitabine and nab-paclitaxel, with each course lasting 28 days. If no safety issues are found after the start of the second course, the dose may be increased to 180 mg once daily.

Outcome(s)

Primary Outcome	Response rate at 48 weeks after the start of the clinical trial (RECIST evaluation; the response rate is defined as the percentage of patients whose best overall response is either CR or PR).
Secondary Outcome	Progression-free survival Overall survival Disease control rate

Key inclusion & exclusion criteria

Age minimum	>= 20age old
Age maximum	Not applicable
Gender	Both
Include criteria	1) The following conditions must be met regarding the histological or cytological examination of the primary or metastatic lesion: (1)Diagnosed as invasive pancreatic ductal carcinoma* by histological examination, and imaging studies also determined to be consistent with invasive pancreatic ductal carcinoma*. (2)Diagnosed as Class 4 or Class 5 by cytological examination, and imaging studies also determined to be consistent with invasive pancreatic ductal carcinoma*. *Among invasive pancreatic ductal carcinomas, only adenocarcinoma (well-differentiated, moderately differentiated, poorly differentiated) and adenosquamous cell carcinoma (see "Histological Classification (Pancreatic Cancer Treatment Guidelines, 8th Edition)"). 2) Pancreatic cancer with distant metastasis or recurrent pancreatic cancer as determined by chest CT and abdominal/pelvic contrast-enhanced CT or abdominal/pelvic contrast-enhanced MRI. 3) Ascites is moderate or less as determined by abdominal/pelvic contrast-enhanced CT or abdominal/pelvic contrast-enhanced MRI. 4) No metastasis to the central nervous system (brain, spinal cord, meninges) with symptoms (head CT or head MRI prior to registration is not mandatory). 5) The patient is 20 years of age or older on the registration date. 6) Performance status (PS) is 0 or 1 according to the ECOG criteria. 7) On imaging studies performed within 28 days prior to the start of the trial, the patient has one or more measurable lesions as defined in RECIST Guideline 1.1. 8) The patient has no history of chemotherapy or radiotherapy for pancreatic cancer. However, recurrent pancreatic cancer patients who have received adjuvant chemotherapy with S-1 or GEM therapy are eligible if the period from the last adjuvant chemotherapy dose to the date of recurrence confirmation is 24 weeks or more (recurrence on the same day of the week 24 weeks after the last dose is acceptable). Also, recurrent pancreatic cancer patients who have received neoadjuvant chemotherapy followed by adjuvant chemotherapy with S-1 or gemcitabine therapy are eligible, regardless of the content of the neoadjuvant chemotherapy regimen. 9) The patient does not have chronic watery stools. 10) The patient does not have peripheral sensory neuropathy (Grade 2 or higher) or peripheral motor neuropathy (Grade 2 or higher). 11) Oral administration is possible. 12) The most recent test results within 7 days prior to registration (the same day of the week one week prior to registration is acceptable) meet all of the following criteria: (1) White blood cell count <= 10,000/mm3 (2) Neutrophil count >= 1,500/mm3 (3) Hemoglobin >= 9.0 g/dL (No blood transfusions were performed within 7 days prior to the blood collection date for the test used for registration) (4) Platelet count >= 100,000/mm3 (5)Total bilirubin <= 1.5 mg/dL (6) AST <= 100 U/L (7) ALT <=100 U/L (8)eGFR >= 50 ml/min/1.73 m2 13) Not diagnosed with dementia. However, even if diagnosed with dementia, if the clinical trial physician determines that family support is available and that protocol treatment can be implemented and continued, the patient is eligible. 14) Written informed consent has been obtained from the patient to participate in the clinical trial.
Exclude criteria	1) Having active multiple cancers (synchronous multiple cancers/multiple cancers and metachronous multiple cancers/multiple cancers with a disease-free period of 5 years or less. However, even if the disease-free period is less than 5 years, a history of cancers with a 5-year relative survival rate of 95% or more, such as clinical stage 1 prostate cancer, clinical stage 0 or 1 laryngeal cancer that achieved complete response with radiation therapy, or cancers with the following pathological stages that were completely resected, is not included in active multiple cancers/multiple cancers). Gastric cancer adenocarcinoma (general type): Stage 0-1, Colon cancer (adenocarcinoma): Stage 0-1, Rectal cancer (adenocarcinoma): Stage 0-1, Esophageal cancer (squamous cell carcinoma, adenosquamous cell carcinoma, basal cell carcinoma): Stage 0, Breast cancer (ductal carcinoma in situ, lobular carcinoma in situ): Stage 0, Breast cancer (invasive ductal carcinoma, invasive lobular carcinoma, Pagets disease): Stage 0-2A, Endometrial cancer (endometrioid adenocarcinoma, mucinous adenocarcinoma): Stage 1, Prostate cancer (adenocarcinoma): Stage 1-2, Cervical cancer (squamous cell carcinoma): Stage 0, Thyroid cancer (papillary carcinoma, follicular carcinoma): Stage 1, 2, 3, Renal cancer (clear cell carcinoma, chromophobe cell carcinoma): Stage 1, Other lesions equivalent to intramucosal carcinoma *Stage classification follows, in principle, the UICC-TNM 9th edition or equivalent cancer treatment guidelines. 2) Has an infection requiring systemic treatment. 3) Having a fever of 38.0 degrees Celsius or higher at the time of registration. 4) Women who are pregnant, possibly pregnant, within 28 days postpartum, or breastfeeding. Men who wish for their partner to become pregnant. 5) Having a mental illness or symptoms that interfere with daily life and making participation in the study difficult. 6) Receiving continuous systemic administration (oral or intravenous) of steroids or other immunosuppressants. 7) Having one or more of the following conditions diagnosed by chest CT: interstitial pneumonia, pulmonary fibrosis, or severe emphysema. 8) Having serious complications (such as heart failure, renal failure, hepatic failure, intestinal paralysis, intestinal obstruction, poorly controlled diabetes, or poorly controlled hypertension). 9) Having unstable angina (angina that has started or worsened within the last 3 weeks), or a history of myocardial infarction within the last 6 months. 10) Continuous use of one or more of the following is necessary:flucytosine (Ancotil, Domerazine, Alcytosine, Cocol), phenytoin (Aleviatin, Hydantoin, Phenytoin N), warfarin potassium (Alefarin, Samofalon, Warfarin), dabigatran etexilate methanesulfonate (Pradaxa), rivaroxaban (Xarelto), apixaban (Eliquis), edoxaban tosylate hydrochloride hydrate (Lixiana), heparin sodium, or tissue-type plasminogen activator (t-PA) (Activasin, Glutopa, Clearactor). 11) Due to drug allergies, neither iodine-based nor gadolinium-based drugs can be used. 12) A history of severe drug hypersensitivity to either nab-paclitaxel (paclitaxel (albumin-bound)) or gemcitabine. 13) Any other patient deemed unsuitable by the clinical trial physician.