Phase1/2 study of endoscopic photodynamic therapy using ME2906 and ultrathin PDT probe in unresectable bile duct cancer

JRCT ID: jRCT2041220118

Registered date:16/01/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Unresectable bile duct cancer
• Date of first enrollment: 03/02/2023
• Target sample size: 53
• Study type: Interventional
• Intervention(s): PDT

Outcome(s)

Primary Outcome

Phase Ia,Ib
The occurrence of IEDLT

Phase II
6M Non-RBO survival rate

Secondary Outcome

Phase 1a
Overall survival
The findings of cholangioscopy
Adverse events rate, complications rate
Photosensitive reaction on skin
Technical success rate
Clinical success rate
Defect of investigational device and equipment

Phase 1b
Overall survival
Adverse events rate, complications rate
Photosensitive reaction on skin
Technical success rate
Clinical success rate
Defect of investigational device and equipment

Phase II
Non-RBO survival rate
TRBO
PFS
OS
Adverse events rate, complications rate
Photosensitive reaction on skin
Technical success rate
Clinical success rate
Defect of investigational device and equipment

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Phase I and II
(1) Given written consent to participate in the clinical trial of own will.
(2) Age 20 years or older at the time consent is obtained.
(3) Patient has a cytological diagnosis of class IV or V or a histological diagnosis of adenocarcinoma or adenosquamous carcinoma.
(4) Patient with malignant biliary obstruction.
(5) Patient with ECOG Performance Status (ECOG PS) of 0 or 1.
(6) Expected to survive more than 12 weeks.
(7) Serum total bilirubin <=6.0 mg/dL with appropriate biliary drainage.
(8) Patient with well-preserved major organ function
(9) Patient who can stay in a room of 500 lux or less for 2 weeks after administration of the investigational drug.

Phase I only
(1)Refractory or intolerant to standard primary chemotherapy or in best supportive care.
(2)Patient has unresectable hilar cholangiocarcinoma.

Phase II only
(1)Patient has unresectable extrahepatic cholangiocarcinoma.
(2)Patient has unresectable extrahepatic cholangiocarcinoma and has not been treated with radiation therapy or chemotherapy for unresectable extrahepatic cholangiocarcinoma.
(3)Patient is scheduled to start standard chemotherapy.

Exclude criteria

(1) Symptomatic brain metastases or meningeal dissemination.
(2) Pregnant or possibly pregnant, lactating women, or women who wish to be pregnant before completion of the follow-up period of this study.
(3) Unable to use adequate contraceptive methods (e.g., condoms, pessaries, etc.) or unable to obtain adequate contraceptive consent from the time of obtaining consent until the completion of the follow-up period of this study.
(4) History of other malignancy within 3 years prior to enrollment.
(5) Malignant biliary duct obstruction after biliary metal stent placement.
(6) History of chronic cholangitis such as primary sclerosing cholangitis or IgG4-related cholangitis.
(7) Surgical biliary reconstruction.
(8) Clinically diagnosed with cirrhosis (Child-Pugh classification B or C).
(9) History or complication of photosensitivity or porphyria.
(10) History or complication of hypersensitivity to talaporphine sodium.
(11) Difficulty inserting an endoscope orally.
(12) Patient with infection requiring systemic treatment.
(13) Patient with uncontrolled hypertension, diabetes mellitus, serious cardiac disease, or renal disorder.
(14) Patient with other serious acute or chronic medically significant abnormalities.
(15) Patient with massive ascites requiring puncture drainage or other treatment.
(16) Patient with active hepatitis virus
(17) Patient with participating in or has completed participation in another clinical trial for less than 3 months.
(18) Physician determines that the patient is not suitable for enrollment in this clinical trial.

Related Information

• Primary Sponsor: Sato Junya