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

Phase 1

Recruiting

• Conditions: nresectable bile duct cancer

• Registration Number: JPRN-jRCT2041220118
• Lead Sponsor: Sato Junya

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-16
• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 53

Inclusion 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.

Exclusion 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Phase Ia,Ib<br>The occurrence of IEDLT<br><br>Phase II<br>6M Non-RBO survival rate

Secondary Outcome Measures

Name	Time	Method
Phase 1a<br>Overall survival<br>The findings of cholangioscopy<br>Adverse events rate, complications rate<br>Photosensitive reaction on skin<br>Technical success rate<br>Clinical success rate<br>Defect of investigational device and equipment<br><br>Phase 1b<br>Overall survival<br>Adverse events rate, complications rate<br>Photosensitive reaction on skin<br>Technical success rate<br>Clinical success rate<br>Defect of investigational device and equipment<br><br>Phase II<br>Non-RBO survival rate<br>TRBO<br>PFS<br>OS<br>Adverse events rate, complications rate<br>Photosensitive reaction on skin<br>Technical success rate<br>Clinical success rate<br>Defect of investigational device and equipment