Case Report
Copyright ©The Author(s) 2025. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Clin Oncol. Jun 24, 2025; 16(6): 105910
Published online Jun 24, 2025. doi: 10.5306/wjco.v16.i6.105910
Durable complete response to sintilimab plus chemotherapy in gallbladder cancer with extensive metastasis: A case report
Feng Wang, Xin-Lei Gong, Xin-Ni Chen, Zhi-Hui Yang, Xiao-Yuan Chu
Feng Wang, Xin-Lei Gong, Xin-Ni Chen, Xiao-Yuan Chu, Department of Oncology, Affiliated Jinling Hospital, Medical School of Nanjing University, Nanjing 210002, Jiangsu Province, China
Zhi-Hui Yang, Department of Pathology, Affiliated Jinling Hospital, Medical School of Nanjing University, Nanjing 210002, Jiangsu Province, China
Author contributions: Wang F and Chu XY had full access to all data in the study and take responsibility for data integrity and the accuracy of data analysis; Gong XL contributed to the study concept and design; Wang F, Gong XL, Chen XN, Yang ZH, and Chu XY acquired, analyzed and interpreted data. Chen XN and Yang ZH supervised the analysis. All authors read, critically revised, and approved the final manuscript.
Informed consent statement: Informed written consent was obtained from the patient for publication of this report and any accompanying images.
Conflict-of-interest statement: All the authors report no relevant conflicts of interest for this article.
CARE Checklist (2016) statement: The authors have read the CARE Checklist (2016), and the manuscript was prepared and revised according to the CARE Checklist (2016).
Open Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Xiao-Yuan Chu, MD, Department of Oncology, Affiliated Jinling Hospital, Medical School of Nanjing University, No. 305 Zhongshan East Road, Xuanwu District, Nanjing 210002, Jiangsu Province, China. chuxiaoyuan00@gmail.com
Received: February 18, 2025
Revised: April 11, 2025
Accepted: May 23, 2025
Published online: June 24, 2025
Processing time: 122 Days and 12 Hours
Abstract
BACKGROUND

Gallbladder cancer is a highly malignant and aggressive tumor, often diagnosed at an advanced stage. The prognosis for advanced gallbladder cancer remains poor, with limited options for effective treatment.

CASE SUMMARY

A 65-year-old male patient presented with a soft tissue mass in the gallbladder. Following laparoscopic exploration, he underwent radical surgery for gallbladder cancer, with the tumor staged as pT2N1M0 (stage III). Post-surgery, the patient received four cycles of adjuvant chemotherapy. However, one month later, over 60 metastatic lesions were detected in the liver, lungs, and lymph nodes. In response to the widespread metastasis, he underwent six cycles of combination therapy consisting of sintilimab, albumin-bound paclitaxel, and cisplatin. After two cycles, a partial response was achieved. Maintenance therapy was initiated with a combination of sintilimab and albumin-bound paclitaxel for four cycles. Monotherapy with sintilimab was continued thereafter until October 2023. Complete remission was confirmed in September 2021. The patient sustained this complete response for more than three years, including an eleven-month period without disease progression following the discontinuation of sintilimab. Genetic analysis revealed a tumor mutational burden of 15.4 mutations/megabase, which indicates a potentially favorable response to immunotherapy.

CONCLUSION

This case demonstrates the potential of combining immunotherapy (sintilimab) with chemotherapy to achieve durable remission in metastatic gallbladder cancer, even in a patient with extensive metastasis. In addition, it indicated the importance of tumor mutational burden as a predictive biomarker of immunotherapy.

Keywords: Gallbladder cancer; Immunotherapy; Sintilimab; Complete response; Tumor mutational burden; Extensive metastasis; Case report

Core Tip: We present a rare case of metastatic gallbladder cancer with over sixty liver, lung, and lymph node metastases achieving durable complete remission via sintilimab combined with albumin-bound paclitaxel and cisplatin. Following six cycles, complete response was maintained for over three years, including eleven months post-treatment. High tumor mutational burden (15.4 mutations/megabase) predicted immunotherapy efficacy. This highlights the potential of programmed death-1 inhibitors with chemotherapy in advanced disease and emphasizes tumor mutational burden’s role as a predictive biomarker.