Phase II Trial to Evaluate the Efficacy and Safety of Combination Therapy with Immune Checkpoint Inhibitors and Photodynamic Therapy

JRCT ID: jRCT2051220176

Registered date:27/02/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Esophageal cancer, Gastric cancer
• Date of first enrollment: 27/02/2023
• Target sample size: 80
• Study type: Interventional

Intervention(s)

Cohort A: Nivolumab(240mg, every 2 weeks or 360mg, every 3 weeks)+Ipilimumab(1mg/kg, every 6 weeks)+PDT(talaporfin sodium40mg/m2)
Cohort B: Nivolumab(360mg, every 3 weeks)+CapeOX(Capecitabine and oxaliplatin should be used according to the package insert)+PDT, Nivolumab(360mg, every 3 weeks)+SOX(S-1 and oxaliplatin should be used according to the package insert)+PDT(talaporfin sodium40mg/m2)
Cohort C: Nivolumab(480mg, every 4 weeks)+PDT(talaporfin sodium40mg/m2)

Outcome(s)

• Primary Outcome: Response rate for each cohort

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

The patient with unresectable or recurrent esophageal cancer or gastric cancer are eligible. Even if there is stenosis, if PD laser irradiation is judged to be safely possible, the patient is also acceptable, including gastrostomy case.
The patient has a lesion in the esophagus or stomach that can be irradiated with the PD laser. However, in the case of esophageal cancer, the irradiated lesion must not extend into thecervical esophagus.
Evaluable distant metastasis or lymph node metastasis.
The lesion to be PD-lasered does not invade the aorta (greatvessels) or airways (trachea, bronchus, lungs, etc.). If the primary lesion invades the aorta or airway, it is acceptable if there are other lesions that can be safely irradiated (simultaneousmultiple lesions, intramural metastases, etc.). However, imaging or clinical evidence of primary lesions invading the aorta (great vessels) or airway (trachea, bronchus, lungs, etc.) with esophageal perforation, esophageal airway (branch) fistula, esophageal longitudinal fistula, bleeding or airway stenosis symptoms associated with arterial invasion is ineligible.
The patient must be at least 18 years old at the time consent is obtained.
ECOG PS of 0-1.
The patient must have major organ function.
Written consent for participation in the clinical trial has been obtained from the patient.
Agrees to use contraception from the time of consent until at least 5 months after the last administration of the ICI if the patient is a woman of childbearing potential or a man whose partner is of childbearing potential.
Agrees not to breastfeed from the time consent is obtained until at least 5 months after the last dose of ICI.

Exclude criteria

Has been diagnosed with HER2-positive gastric cancer.
Has active multiple primary cancer. However, the following metachronous or simultaneous cabcer is eligible regardless of cancer type, stage, or treatment history.
The patient does not require systemic therapy (chemotherapy, immunotherapy, endocrine therapy, etc.) for more than 6 months.
The patient is expected to be cured by local therapy such as endoscopic therapy.
The patient has the following serious complications.
Poorly controlled hypertension
Poorly controlled diabetes mellitus
Severe hepatic disorder (cirrhosis, etc.)
Serious cardiac disease (myocardial infarction, angina pectoris, congestive heart failure, etc.)
Serious renal disorder
Serious pulmonary disorder (interstitial lung disease, pulmonary fibrosis, COPD, etc.)
Systemic infectious diseases requiring treatment.
The investigator/appointed investigator determines that the patient is incapable of light shielding or other lifestyle restrictions.
CT at the time of diagnosis shows aortic or tracheal invasion of the primary tumor, and imaging or clinical signs of esophageal perforation, esophageal airway (branch) fistula, esophageal mediastinal fistula, bleeding associated with arterial invasion, or airway stenosis symptoms.
Complicated porphyria.
Has a history of or concomitant photosensitivity.
Previous PDT with thalaporphine sodium or porphymer sodium (esophageal cancer only).
Complicated or history of severe hypersensitivity reactions to other antibody products.
Complicated autoimmune disease or history of chronic or recurrent autoimmune disease, except for endocrine disorders such as hypothyroidism, hypoadrenalism, hypopituitarism, and type I diabetes mellitus, which are controlled by hormone replacement therapy, etc.
The presence of pericardial, pleural, or ascites effusions requiring medical attention.
Tumor-related pain that is not stable and controlled.
Pregnant or possibly pregnant women. Women who are lactating. Men and women who do not agree to use contraception during the clinical trial.
The patient with severe bleeding or shock.
The patient with bleeding tendency.
The patient with conditions requiring systemic treatment with either systemic corticosteroids (prednisolone equivalent daily dose > 10 mg) or other immunosuppressive agents within 14 days prior to initiation of protocol therapy, except for temporary use for testing or prophylactic administration for allergic reactions. The use of inhaled or topical steroids and adrenal replacement steroids is allowed in the absence of active autoimmune disease.
The patient has received a live vaccine within 30 days prior to enrollment in this study.
Either the HBs antigen test or the HCV antibody test is positive.
HBs antigen test is negative, but either HBs antibody or HBc antibody test is positive and HBV-DNA quantification is above detection sensitivity.
The patient who is judged to lack the capacity to consent due to complications of dementia or other conditions.
The patient who is currently participating in another clinical trial or who has not completed another clinical trial within 3 months of completion.
The patient whom the investigators/associate investigators deem inappropriate for the safe conduct of this clinical trial.

Related Information

• Primary Sponsor: Muto Manabu
• Source(s) of Monetary Support: Meiji Seika Pharma Co., Ltd.