Sintilimab plus nab-paclitaxel as second-line treatment for advanced biliary tract cancer: study protocol for an investigator-initiated phase 2 trial (NapaSinti trial)

Article Oncology

Regorafenib-avelumab combination in patients with biliary tract cancer (REGOMUNE): a single-arm, open-label, phase II trial

Sophie Cousin et al.

Summary: Regorafenib combined with avelumab demonstrates antitumour activity in heavily pretreated biliary tract cancer patients, with a correlation to tumor microenvironment features.

EUROPEAN JOURNAL OF CANCER (2022)

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Article Oncology

Combination chemotherapy with NAB(R)-paclitaxel and capecitabine for patients with advanced biliary tract cancer (NAP-CAPABIL Pilot Study)

Rachel Woodford et al.

Summary: This study demonstrates the feasibility and potential efficacy of combination therapy with capecitabine and nab-paclitaxel as a second-line treatment for ABTC, warranting further assessment in formal phase II or III trials. The treatment was generally well tolerated, with encouraging disease control rates and survival outcomes.

ASIA-PACIFIC JOURNAL OF CLINICAL ONCOLOGY (2022)

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Article Oncology

Tolerability and efficacy of durvalumab, either as monotherapy or in combination with tremelimumab, in patients from Asia with advanced biliary tract, esophageal, or head-and-neck cancer

Yuichiro Doki et al.

Summary: This study evaluated the safety, tolerability, and antitumor activity of durvalumab monotherapy and durvalumab plus tremelimumab combination therapy in Asian patients with biliary tract cancer, esophageal squamous cell carcinoma, or head and neck squamous cell carcinoma. The results demonstrated acceptable safety profiles and clinical benefit in these patients.

CANCER MEDICINE (2022)

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Article Gastroenterology & Hepatology

Gemcitabine and cisplatin plus durvalumab with or without tremelimumab in chemotherapy-naive patients with advanced biliary tract cancer: an open-label, single-centre, phase 2 study

Do-Youn Oh et al.

Summary: In patients with advanced biliary tract cancer, gemcitabine and cisplatin plus immunotherapy showed promising efficacy and acceptable safety, with an objective response rate of 66%. The most common adverse events were hematological, with no unexpected safety events observed.

LANCET GASTROENTEROLOGY & HEPATOLOGY (2022)

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Article Oncology

Second-line FOLFOX chemotherapy versus active symptom control for advanced biliary tract cancer (ABC-06): a phase 3, open-label, randomised, controlled trial

Angela Lamarca et al.

Summary: This study found that second-line FOLFOX chemotherapy can significantly improve overall survival in patients with advanced biliary tract cancer after progression on cisplatin and gemcitabine, indicating it should be considered as standard-of-care chemotherapy.

LANCET ONCOLOGY (2021)

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Meeting Abstract Oncology

Lenvatinib plus pembrolizumab for patients with previously treated biliary tract cancers in the multicohort phase 2 LEAP-005 study.

Luis Villanueva et al.

JOURNAL OF CLINICAL ONCOLOGY (2021)

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Article Oncology

Sintilimab Plus Platinum and Gemcitabine as First-Line Treatment for Advanced or Metastatic Squamous NSCLC: Results From a Randomized, Double-Blind, Phase 3 Trial (ORIENT-12)

Caicun Zhou et al.

Summary: A randomized, double-blind, phase 3 study found that Sintilimab plus GP showed better progression-free survival compared to GP alone in first-line treatment for patients with locally advanced or metastatic sqNSCLC. The toxicity of the treatment was acceptable, and no new unexpected safety signals were observed.

JOURNAL OF THORACIC ONCOLOGY (2021)

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Article Oncology

Pertuzumab and trastuzumab for HER2-positive, metastatic biliary tract cancer (MyPathway): a multicentre, open-label, phase 2a, multiple basket study

Milind Javle et al.

Summary: The study evaluated the activity of pertuzumab plus trastuzumab in patients with HER2-positive metastatic biliary tract cancer. The results showed a promising response rate and good tolerability, suggesting the need for further randomized, controlled trials in this patient population.

LANCET ONCOLOGY (2021)

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Article Oncology

Sintilimab plus a bevacizumab biosimilar (IBI305) versus sorafenib in unresectable hepatocellular carcinoma (ORIENT-32): a randomised, open-label, phase 2-3 study

Zhenggang Ren et al.

Summary: The study aimed to assess the efficacy of sintilimab plus IBI305 versus sorafenib as a first-line treatment for unresectable HBV-associated hepatocellular carcinoma in China, showing significant overall survival and progression-free survival benefits with acceptable safety profiles.

LANCET ONCOLOGY (2021)

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Article Medicine, Research & Experimental

Multicenter randomized phase II trial of atezolizumab with or without cobimetinib in biliary tract cancers

Mark Yarchoan et al.

Summary: The combination of atezolizumab plus cobimetinib showed prolonged progression-free survival compared to atezolizumab monotherapy, indicating potential benefit in biliary tract cancers. However, the low response rate in both arms suggests the immune-resistant nature of BTCs.

JOURNAL OF CLINICAL INVESTIGATION (2021)

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Article Oncology

Real-world efficacy and safety of nab-paclitaxel plus gemcitabine-cisplatin in patients with advanced biliary tract cancers: a multicenter retrospective analysis

Jaekyung Cheon et al.

Summary: Gem/Cis/nab-P demonstrated favorable real-world efficacy and safety outcomes in Korean patients with advanced BTC, which were in line with the outcomes of the phase II trial.

THERAPEUTIC ADVANCES IN MEDICAL ONCOLOGY (2021)

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Article Oncology