Advanced esophageal cancer
Conditions
Interventions
Exploratory Group:Light Doses + Laser Irradiation Time Points
Expansion group:Proper Light Doses and Laser Irradiation Time Points
Sponsors
Beijing Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. All subjects or their legal representatives must voluntarily sign the informed consent approved by the ethics committee in writing before starting any screening process; 2. Patients with age >= 18 years old, regardless of gender; 3. Patients confirmed as primary esophageal cancer by pathological diagnosis, and patients with esophageal or gastroesophageal anastomotic lesions judged by the researchers, and all of the following conditions are met: (1) Not suitable for operation or refused operation; (2) Those who are not suitable for radiotherapy or refuse radiotherapy or fail to receive radiotherapy; (3) Failure or refusal of chemotherapy after standard chemotherapy; 4. According to stooler's dysphagia grade, patients with dysphagia grade 2 or above of esophageal cancer; 5. Starting from the administration of sodium huaporphyrin, the last anti-tumor treatment (including radiotherapy, biotherapy, or other research drugs) was stopped for at least 4 weeks, but the stopping time of oral chemotherapy drugs (such as cassicitabine, tegio, etc.) could be 2 weeks; 6. Subjects with ECoG score of 0 or 1; 7. Subjects with expected survival >= 3 months; 8. The subjects have sufficient organ and bone marrow functions to meet the following laboratory test standards: (1) Bone marrow function: absolute neutrophil count (ANC) >= 1.5 x 10^9 / L (1500 / mm3); platelets >= 100 x 10^9 / L (1 x 10^5 / mm3); (2) Hemoglobin >= 10.0 g / dl; (3) Liver function: serum total bilirubin = 60 ml / min; (5) Coagulation function: INR <= 1.5 x ULN, APTT <= 1.5 x ULN. 9. Women of childbearing age and all male subjects must agree to use highly effective contraceptive methods within 12 months after the trial and the last use of sodium porphyrin (condom, contraceptive sponge, contraceptive gel, contraceptive membrane, intrauterine device, oral or injectable contraceptive, subcutaneous implant, etc.), and the results of pregnancy test within the period of less than 7 days before the test drug is given to women of childbearing age. Must be negative.
Exclusion criteria
Exclusion criteria: 1. Patients who are known to be allergic to HPD or other photosensitive drugs; 2. Subjects who participated in any other drug clinical trial or other intervention clinical trial within 4 weeks before the administration of HPD, except those who participated in the observation (non intervention) clinical trial or have been in the follow-up period of the intervention study; 3. Patients who have received photosensitizer treatment before; 4. Patients who used other photosensitive drugs (tetracycline antibiotics, sulfonamides, phenothiazines, sulfonylureas, Thiazines, griseofulvin, etc.) within 4 weeks before administration of HPD; 5. Patients with esophagotracheal fistula, esophago mediastinal fistula, or the risk of tumor invading the surrounding large blood vessels confirmed by endoscopy or other examinations; 6. Patients who have not recovered (judged by the researcher) from the toxic reaction of anti-tumor treatment before administration of HPD, or patients who have not recovered completely (judged by the researcher) from the previous operation; 7. Patients who are in a bad fluid state or are expected to be unable to tolerate photodynamic therapy for advanced tumors; 8. Patients not suitable for endoscopy; 9. Patients who need to be combined with any other anti-tumor treatment during the treatment period of the trial drug, including chemotherapy, immunotherapy, biological agent treatment, etc; 10. Patients with acute inflammation (especially corrosive inflammation) or clinically significant active infection; 11. Patients with active hepatitis B (defined as HBV DNA >= 2000 IU / ml or HBV DNA >= 104 copies) who are positive in any one or more of the test results of hepatitis C virus (HCV) antibody, Treponema pallidum antibody or human immunodeficiency virus (HIV) antibody; twelve Patients with severe or uncontrolled cardiovascular and pulmonary diseases (including myocardial infarction, grade III-IV heart failure as defined by NYHA, cardiac insufficiency, heart block above level 2, severe arrhythmia, or, in the judgment of the investigator, inability to respond to increased risk of ventricular arrhythmia due to heart disease, asthma attack, or respiratory failure) Lie flat, etc.); 13. Patients with uncontrolled mental illness or certain social conditions are expected to limit their compliance with the study requirements, or impair their ability to sign informed consent in writing; 14. Pregnant or lactating women; 15. According to the researcher's judgment, there are other reasons that are not suitable for the study, such as patients with large esophageal tumor focus.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tolerance of subjects under different laser irradiation conditions;Adverse events (type, incidence, severity); | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Dysphagia index;Quality of life;the durative time of remission ;Total survival; | — |
Countries
China
Contacts
Public ContactShen Lin
Beijing Cancer Hospital
Outcome results
None listed