Feasibility and tolerability of sintilimab plus anlotinib as the second‐line therapy for patients with advanced biliary tract cancers: An open‐label, single‐arm, phase <scp>II</scp> clinical trial

Jin, Shuiling; Zhao, Ruihua; Zhou, Chuang; Zhong, Qian; Shi, Jianxiang; Su, Chang; Li, Qinglong; Su, Xiaoxing; Chi, Huabin; Lu, Xu; Jiang, Guozhong; Chen, Renyin; Han, Jinming; Jiang, Miao; Qiao, Shan; Liu, Jingjing; Song, Min Seob; Song, Lijie; Du, Yabing; Chang, Zhiwei; Wang, Meng; Dong, Meilian; Zhong, Yali; Yu, Pu; Zhang, Xiaojian; Zong, Hong

doi:10.1002/ijc.34372

Cited by 14 publications

(19 citation statements)

References 52 publications

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“…Two studies with a total of 44 patients evaluated the role of gut microbiota in response to programmed cell death receptor-1 (PD-1) antagonists in patients suffering from CCA [ 52 , 53 ]. Both studies reported the results of patients with advanced-stage disease after failure of first-line treatment.…”

Section: Resultsmentioning

confidence: 99%

Gut Microbiota in Diagnosis, Therapy and Prognosis of Cholangiocarcinoma and Gallbladder Carcinoma—A Scoping Review

Lederer,

Rasel,

Kohnert

et al. 2023

Microorganisms

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Cancers of the biliary tract are more common in Asia than in Europe, but are highly lethal due to delayed diagnosis and aggressive tumor biology. Since the biliary tract is in direct contact with the gut via the enterohepatic circulation, this suggests a potential role of gut microbiota, but to date, the role of gut microbiota in biliary tract cancers has not been elucidated. This scoping review compiles recent data on the associations between the gut microbiota and diagnosis, progression and prognosis of biliary tract cancer patients. Systematic review of the literature yielded 154 results, of which 12 studies and one systematic review were eligible for evaluation. The analyses of microbiota diversity indices were inconsistent across the included studies. In-depth analyses revealed differences between gut microbiota of biliary tract cancer patients and healthy controls, but without a clear tendency towards particular species in the studies. Additionally, most of the studies showed methodological flaws, for example non-controlling of factors that affect gut microbiota. At the current stage, there is a lack of evidence to support a general utility of gut microbiota diagnostics in biliary tract cancers. Therefore, no recommendation can be made at this time to include gut microbiota analyses in the management of biliary tract cancer patients.

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Section: Resultsmentioning

confidence: 99%

Gut Microbiota in Diagnosis, Therapy and Prognosis of Cholangiocarcinoma and Gallbladder Carcinoma—A Scoping Review

Lederer,

Rasel,

Kohnert

et al. 2023

Microorganisms

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“… 29 Anlotinib has been authorized for the treatment of patients diagnosed with acinar soft tissue sarcoma, clear cell sarcoma, and other recurrent advanced soft tissue sarcomas. 30 , 31 After fully informing the patient of their condition, the patient received a combination of sintilimab, anlotinib and paclitaxel albumin every 3 weeks as the initial therapeutic approach following comprehensive discussion and evaluation. Following two cycles of this treatment regimen, the patient’s abdominal CT scan revealed a reduction in liver lesions, as well as significant shrinkage in gallbladder lesions and lymph nodes compared to previous scans.…”

Section: Discussionmentioning

confidence: 99%

Long-Term Follow-Up of Combination Therapy with Sintilimab and Anlotinib in Gallbladder Follicular Dendritic Cell Sarcoma: A Rare Case Report

Yan,

Zhang,

et al. 2024

OTT

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Follicular dendritic cell sarcoma (FDCS) is a rare malignant neoplasm for which a standardized treatment approach has yet to be established. The prevailing therapeutic strategy typically involves resection followed by adjuvant chemotherapy or radiation. This case report details the long-term follow-up of a 59-year-old Chinese male diagnosed with gallbladder FDCS and liver metastases. The patient received a combination therapy of sintilimab and anlotinib, resulting in a substantial partial response (PR) lasting for a noteworthy duration of 30 months. Notably, this is the first documented instance of gallbladder FDCS with liver metastases being treated with PD-1 antibody and antiangiogenic agents as first-line therapy. These findings suggest that this treatment regimen may offer a potential therapeutic option for patients with gallbladder FDCS and liver metastases, with a duration of PR lasting up to 30 months.

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“…Furthermore, compared to nivolumab and toripalimab which were widely used for ECC, patients faced much fewer financial burdens. Additionally, these two PD-1 inhibitors have been proven to be effective and safe in advanced ECC trials ( 36 , 37 ). Third, we did not further evaluate microsatellite instability-high status, mismatch repair protein deficiency, and programmed death-ligand 1 before using the PD-1 inhibitor.…”

Section: Discussionmentioning

confidence: 99%

Safety and efficacy of biliary stenting combined with iodine-125 seed strand followed by hepatic artery infusion chemotherapy plus lenvatinib with PD-1 inhibitor for the treatment of extrahepatic cholangiocarcinoma with malignant obstructive jaundice

Lin,

Ke,

Chen

et al. 2024

Front. Immunol.

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ObjectivesTo evaluate the efficacy and safety of biliary stenting implantation with iodine-125 seed strand (SI) followed by hepatic artery infusion chemotherapy (HAIC) plus lenvatinib (Len) with programmed death-1 (PD-1) inhibitor for patients diagnosed with extrahepatic cholangiocarcinoma (ECC) and malignant obstructive jaundice (MOJ).MethodsIn this single-center retrospective study, the data of ECC patients with MOJ from March 2015 to January 2023 was assessed. Using probability score matching (PSM), the selection bias of patients was reduced. Primary study outcomes included overall survival (OS) and progression-free survival (PFS). The OS and PFS were performed using the Kaplan–Meier method and evaluated with the log-rank test.ResultsA total of 104 patients were enrolled finally, including 52 patients treated with interventional therapy (SI+HAIC) plus Len with PD-1 inhibitor (SI+HAIC+Len+P group) and 52 patients treated with interventional therapy (SI+HAIC) plus lenvatinib (SI+HAIC+Len group). 26 pairs of patients were matched after PSM analysis. After PSM analysis, the median OS and PFS in the SI+HAIC+Len+P group were significantly longer compared to those in the SI+HAIC+Len group (OS:16.6 vs. 12.3 months, P = 0.001; PFS:12.6 vs 8.5 months, P = 0.004). The DCR was significantly different between groups (P = 0.039), while ORR not (P = 0.548). The addition of PD-1 inhibitor was generally well tolerated without treatment-associated mortality.ConclusionInterventional therapy (SI+HAIC) plus Len with PD-1 inhibitor was effective for ECC patients accompanied by MOJ with a manageable safety profile.

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Feasibility and tolerability of sintilimab plus anlotinib as the second‐line therapy for patients with advanced biliary tract cancers: An open‐label, single‐arm, phase II clinical trial

Cited by 14 publications

References 52 publications

Gut Microbiota in Diagnosis, Therapy and Prognosis of Cholangiocarcinoma and Gallbladder Carcinoma—A Scoping Review

Gut Microbiota in Diagnosis, Therapy and Prognosis of Cholangiocarcinoma and Gallbladder Carcinoma—A Scoping Review

Long-Term Follow-Up of Combination Therapy with Sintilimab and Anlotinib in Gallbladder Follicular Dendritic Cell Sarcoma: A Rare Case Report

Safety and efficacy of biliary stenting combined with iodine-125 seed strand followed by hepatic artery infusion chemotherapy plus lenvatinib with PD-1 inhibitor for the treatment of extrahepatic cholangiocarcinoma with malignant obstructive jaundice

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