CHINESE JOURNAL OF DRUG EVALUATION >

2025 , Vol. 42 >Issue 6: 477 - 477-481

DOI: https://doi.org/magtech-2025-04-19-00001

A Prospective， Randomized， Double-blind Controlled Study on the  Efficacy of Tislelizumab Combined with TP Chemotherapy Regimen in the#br#      Treatment of Patients with Intermediate and Advanced Esophageal Cancer

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  • The First People′s Hospital of Pingdingshan City， Henan Pingdingshan 467000， China

Received date: 2025-04-19

  Revised date: 2025-05-24

  Accepted date: 2026-01-07

  Online published: 2026-01-07

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Abstract

Objective： To explore the efficacy and safety of tislelizumab combined with paclitaxel + cisplatin (TP) chemotherapy regimen in the treatment of intermediate and advanced esophageal cancer. Methods： A prospective， randomized， double-blind study was conducted on 106 patients with intermediate and advanced esophageal cancer admitted to our Hospital from January 2021 to January 2023. The patients were randomly assigned to a control group and a study group using a random number table method， with 46 patients in each group. The control group was given a placebo injection combined with the TP chemotherapy regimen， while the study group was given tislelizumab combined with the TP chemotherapy regimen. Both groups underwent treatment for four cycles. The clinical efficacy， toxic and side effects and survival status were compared between the two groups， as well as the immune function (CD3+， CD4+， CD4+/CD8+)， serum tumor disease indicators [carcinoembryonic antigen (CEA)， cysteine-rich protein 61 (Cyr61)， aldehyde-ketone reductase 1B10 (AKR1B10)] before and after treatment. Results： The remission rate and control rate of disease in the study group were higher than those of the control group (P<0.05). After 2 and 4 cycles of treatment， the levels of CD3+， CD4+， and CD4+/CD8+ in the study group were higher than those in the control group， while the levels of serum CEA， Cyr61， and AKR1B10 were lower than those in the control group (P<0.05). During the treatment period， there was no significant difference in the incidence of toxic side effects such as digestive symptoms， abnormal liver function， bone marrow suppression， rash， and hypothyroidism between the two groups (P>0.05). After a follow-up of 24 months， there was no significant difference in survival rate between the two groups (P>0.05). Conclusion： The combination of tislelizumab and TP chemotherapy can enhance the therapeutic effect of intermediate and advanced esophageal cancer， ameliorate immune function， inhibit disease progression， and has high safety.

Key words： ; font-size:medium; ">Esophageal cancer； TP chemotherapy； Tislelizumab； Immune function； Cysteine-rich protein 61； Toxicity and side effects

Cite this article

WU Conghui, YUE Yunxiao, LIU Huichao . A Prospective， Randomized， Double-blind Controlled Study on the  Efficacy of Tislelizumab Combined with TP Chemotherapy Regimen in the#br#      Treatment of Patients with Intermediate and Advanced Esophageal Cancer[J]. CHINESE JOURNAL OF DRUG EVALUATION, 2025 , 42(6) : 477 -477-481 . DOI: magtech-2025-04-19-00001

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