Esophagus cancer
Conditions
Interventions
IIIa-Experimental 1:A single intravenous infusion of 0.2 mg/kg was administered and the infusion was completed within 1 hour avoiding light throughout the medication. Twenty-four hours after drug inje
IIIa-Experimental 2:A single intravenous infusion of 0.2 mg/kg was administered and the infusion was completed within 1 hour avoiding light throughout the medication. Twenty-four hours after drug inje
IIIa-Active Comparator: Docetaxel alone, paclitaxel alone, irinotecan alone, or best supportive care (BSC)
Docetaxel injection:
Dosage form: Injection
Specification :0.5ml:20mg
Dosage: 75-100 mg/m2, i
IIIb-Experimental:A single intravenous infusion of 0.2 mg/kg was admini
Sponsors
Peking University Cancer Hospital & Institute
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) All subjects or their legally authorized representatives must voluntarily sign the informed consent form approved by the ethics committee before initiating any screening procedures. 2) Age >= 18 years old, gender unspecified. 3) Subjects confirmed by pathological diagnosis to have primary locally recurrent or metastatic esophageal cancer (including gastroesophageal junction cancer), with lesions judged by the investigator to be present in the esophagus or gastroesophageal junction (above 2 cm below the gastroesophageal junction), and suitable for second-line or higher treatment (third-line adenocarcinoma or second-line squamous cell carcinoma), and meet all of the following conditions: a. Not suitable for surgery or refusal of surgery. b. Not suitable for radiation therapy or refusal of radiation therapy or failure after radiation therapy. c. Standard chemotherapy failure or refusal of chemotherapy, including but not limited to platinum-based, fluoropyrimidine-based, trastuzumab, pembrolizumab, nivolumab, etc. The staging of lesions for recurrent patients is defined as follows: a. Patients with metastases from the primary lesion, cTNM or pTNM. b. Patients with recurrence after disappearance of the primary lesion (or after resection or radiation therapy or endoscopic resection), rcTNM. 4) Subjects with dysphagia graded according to the Stooler's dysphagia score reaching Grade 2 or above. 5) From the start of administration of the investigational drug, subjects must have discontinued previous antitumor therapy (including radiation therapy, biological therapy, or other investigational drugs) for at least 4 weeks, but oral chemotherapy drugs (such as capecitabine, tegafur, etc.) may be discontinued for 2 weeks. 6) Subjects with an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. 7) Subjects with an expected survival period >= 3 months. 8) Subjects must have sufficient organ and bone marrow function, meeting the following laboratory criteria: a. Bone marrow function: Absolute neutrophil count (ANC) >= 1.5 × 109/L (1500/mm3); Platelets >= 100 × 109/L (1 × 105/mm3); b. Hemoglobin >= 10.0 g/dL; c. Liver function: Serum total bilirubin = 60 mL/min e. Coagulation function: International normalized ratio (INR) <= 1.5 × ULN, activated partial thromboplastin time (APTT) <= 1.5 × ULN. 9) Toxic reactions to previous antitumor therapy must have decreased to Grade 1 or lower before administration of the investigational drug, or subjects must have fully recovered from previous surgery (as determined by the investigator). 10) Reproductive-age women and all male subjects must agree to use highly effective contraceptive methods (such as condoms, contraceptive sponges, contraceptive gels, contraceptive films, intrauterine devices, oral or injectable contraceptives, subdermal implants, etc.) during the trial period and for 12 months after the last use of DVDMS, and reproductive-age women must have a negative pregnancy test result within <= 7 days before administration of the investi
Exclusion criteria
Exclusion criteria: 1) Known allergy to DVDMS (cosiporfin sodium) or other photosensitizing drugs; 2) Subjects who have participated in any other drug clinical trial or other interventional clinical trial within 4 weeks prior to administration of the investigational drug, except for those participating in observational (non-interventional) clinical studies or those already in the follow-up period of an interventional study; 3) Previous treatment with photosensitizing agents; 4) Use of other photosensitizing drugs (such as tetracyclines, sulfonamides, phenothiazines, sulfonylureas, thiazide diuretics, and psoralens) within 4 weeks prior to administration of the investigational drug; 5) Subjects confirmed by endoscopy or other examinations to have esophagotracheal fistula, esophagomediastinal fistula, or tumors at risk of invading surrounding major blood vessels; 6) Subjects in a cachectic state or deemed unable to tolerate photodynamic therapy for advanced tumors; 7) Not suitable for endoscopic examination; 8) Subjects requiring combination with any other antitumor therapy during the investigational drug treatment period, including chemotherapy, immunotherapy, biologic therapy, etc. 9) Subjects with acute inflammation (especially corrosive inflammation) or clinically significant active infections. 10) Positive results for hepatitis C virus (HCV) antibodies, Treponema pallidum antibodies (indicative of syphilis), or human immunodeficiency virus (HIV) antibodies, or subjects with active hepatitis B (defined as HBV DNA >= 2000 IU/mL or HBV DNA >= 104 copies/mL); 11) Subjects with severe or uncontrolled cardiovascular and pulmonary diseases (including myocardial infarction, New York Heart Association [NYHA] Class III-IV heart failure, congestive heart failure, second-degree or higher atrioventricular block, severe arrhythmias, or, as judged by the investigator, patients with heart diseases at increased risk of ventricular arrhythmias, asthma exacerbations, or respiratory failure leading to inability to lie flat); 12) Subjects with uncontrolled psychiatric/social conditions that are expected to limit their compliance with study requirements or impair their ability to provide written informed consent; 13) Pregnant or lactating women; 14) Subjects judged by the investigator to have other reasons unsuitable for participation in this trial, such as those with long lesions of esophageal tumors (>= 10 cm).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR) of intraluminal target lesions (assessed by the investigator based on the endoscopic results at day 28); | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR) of intraluminal target lesions (assessed by the investigator based on the endoscopic results at month 2, month 3 and month 6);Complete Response Rate (ORR) of intraluminal target lesions (assessed by the investigator based on the endoscopic results at day 28, month 2, month 3 and month 6);Disease Control Rate (DCR) of intraluminal target lesions (assessed by the investigator based on the endoscopic results at day 28, month 2, month 3 and month 6);Objective Response Rate (ORR), Complete Response Rate (CRR), and Disease Control Rate (DCR) assessed by a blinded independent review committee (BIRC) based on the endoscopic results at day 28, month 2, month 3, and month 6.;Duration of Response (DOR);Progression-Free Survival (PFS);Time to Progression (TTP);Changes in dysphagia index (assessed at day 28, month 2, month 3 and month 6);Healthy quality of life (assessed at day 28, month 2, month 3 and month 6);6 month survival rate;12 month survival rate;Overall Survival (OS); | — |
Countries
China
Contacts
Public ContactShen Lin
Peking University Cancer Hospital & Institute
Outcome results
None listed