Baseline Characteristics
From June 2, 2022, to November 11, 2024, 186 patients were randomly assigned (124 to the DVDMS-PDT group and 62 to the TPC group). Four participants withdrew after randomization and did not receive any study drug. In the trial group, 102 patients (82.93%) received one session of DVDMS-mediated photodynamic therapy, 2 patients received DVDMS injection but did not undergo photodynamic therapy, and 19 patients (15.45%) received two sessions. In the control group, 20 patients received single-agent docetaxel, 10 received single-agent paclitaxel, and 18 received single-agent irinotecan.
Twenty-eight participants (45.16%) in the control group crossed over to the trial group for sodium porfimer PDT treatment after their 28-day post-treatment visit (26 [92.86%] received one session, and 2 [7.14%] received two sessions).
The baseline characteristics were as follows: mean age 67.6 ± 8.7 years, 32.3% with distant metastasis, 52.2% with grade 3 dysphagia, and 1.1% with grade 4 dysphagia.
As of November 11, 2024, the median follow-up time was 8.90 months (range: XX-XX), with median follow-up times of 9.13 months (range: XX-XX) and 7.52 months (range: XX-XX) for the trial and control groups, respectively.