Acute Kidney Injury in Cancer Patients Receiving Anti-Vascular Endothelial Growth Factor Monoclonal Antibody vs Immune Checkpoint Inhibitors
NCT ID: NCT06119347
Last Updated: 2023-11-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1581 participants
OBSERVATIONAL
2020-01-01
2023-10-10
Brief Summary
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Cancer patients receiving AntiVEGF will be compared to those treated with ICIs to see if the AKI incidence is higher in patients receiving ICIs.
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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AntiVEGF
cancer patients receiving anti-vascular endothelial growth factor monoclonal antibody (AntiVEGF)
AntiVEGF
anti-vascular endothelial growth factor monoclonal antibody drug includes bevacizumab;
ICIs
cancer patients receiving immune checkpoint inhibitors (ICIs).
ICIs
immune checkpoint inhibitors include Pembrolizumab, Sintilimab, toripalimab, Camrelizumab, Tislelizumab.
Interventions
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AntiVEGF
anti-vascular endothelial growth factor monoclonal antibody drug includes bevacizumab;
ICIs
immune checkpoint inhibitors include Pembrolizumab, Sintilimab, toripalimab, Camrelizumab, Tislelizumab.
Eligibility Criteria
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Inclusion Criteria
* Patients must have at least one "Evaluation and Management"visit with a diagnosis of cancer within 12 months before index date (In situ biopsy will not be required, since patients may receive a diagnosis from a biopsy of metastatic site);
* Indication to initiate AntiVEGF or ICIs
Exclusion Criteria
* Patients without baseline Scr value within 12 mon before index date;
* Patients with combination therapy of Anti-VEGF and ICIs ;
* Patients with chronic renal failure
20 Years
ALL
No
Sponsors
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First Affiliated Hospital of Wenzhou Medical University
OTHER
Responsible Party
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Tianxin Chen
Principal Investigator
Locations
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The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Countries
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References
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Kim HR, Sugawara S, Lee JS, Kang JH, Inui N, Hida T, Lee KH, Yoshida T, Tanaka H, Yang CT, Nishio M, Ohe Y, Tamura T, Yamamoto N, Yu CJ, Akamatsu H, Takahashi S, Nakagawa K. First-line nivolumab, paclitaxel, carboplatin, and bevacizumab for advanced non-squamous non-small cell lung cancer: Updated survival analysis of the ONO-4538-52/TASUKI-52 randomized controlled trial. Cancer Med. 2023 Aug;12(16):17061-17067. doi: 10.1002/cam4.6348. Epub 2023 Aug 28.
Holloway RW, Thaker P, Mendivil AA, Ahmad S, Al-Niaimi AN, Barter J, Beck T, Chambers SK, Coleman RL, Crafton SM, Crane E, Ramez E, Ghamande S, Graybill W, Herzog T, Indermaur MD, John VS, Landrum L, Lim PC, Lucci JA, McHale M, Monk BJ, Moore KN, Morris R, O'Malley DM, Reid TJ, Richardson D, Rose PG, Scalici JM, Silasi DA, Tewari K, Wang EW. A phase III, multicenter, randomized study of olvimulogene nanivacirepvec followed by platinum-doublet chemotherapy and bevacizumab compared with platinum-doublet chemotherapy and bevacizumab in women with platinum-resistant/refractory ovarian cancer. Int J Gynecol Cancer. 2023 Sep 4;33(9):1458-1463. doi: 10.1136/ijgc-2023-004812.
Watanabe J, Muro K, Shitara K, Yamazaki K, Shiozawa M, Ohori H, Takashima A, Yokota M, Makiyama A, Akazawa N, Ojima H, Yuasa Y, Miwa K, Yasui H, Oki E, Sato T, Naitoh T, Komatsu Y, Kato T, Hihara M, Soeda J, Misumi T, Yamamoto K, Akagi K, Ochiai A, Uetake H, Tsuchihara K, Yoshino T. Panitumumab vs Bevacizumab Added to Standard First-line Chemotherapy and Overall Survival Among Patients With RAS Wild-type, Left-Sided Metastatic Colorectal Cancer: A Randomized Clinical Trial. JAMA. 2023 Apr 18;329(15):1271-1282. doi: 10.1001/jama.2023.4428.
Bond MJG, Bolhuis K, Loosveld OJL, de Groot JWB, Droogendijk H, Helgason HH, Hendriks MP, Klaase JM, Kazemier G, Liem MSL, Rijken AM, Verhoef C, de Wilt JHW, de Jong KP, Gerhards MF, van Amerongen MJ, Engelbrecht MRW, van Lienden KP, Molenaar IQ, de Valk B, Haberkorn BCM, Kerver ED, Erdkamp F, van Alphen RJ, Mathijssen-van Stein D, Komurcu A, Lopez-Yurda M, Swijnenburg RJ, Punt CJA; Dutch Colorectal Cancer Study Group. First-line systemic treatment strategies in patients with initially unresectable colorectal cancer liver metastases (CAIRO5): an open-label, multicentre, randomised, controlled, phase 3 study from the Dutch Colorectal Cancer Group. Lancet Oncol. 2023 Jul;24(7):757-771. doi: 10.1016/S1470-2045(23)00219-X. Epub 2023 Jun 14.
Mantia CM, McDermott DF. Vascular endothelial growth factor and programmed death-1 pathway inhibitors in renal cell carcinoma. Cancer. 2019 Dec 1;125(23):4148-4157. doi: 10.1002/cncr.32361. Epub 2019 Sep 18.
Hurwitz H, Fehrenbacher L, Novotny W, Cartwright T, Hainsworth J, Heim W, Berlin J, Baron A, Griffing S, Holmgren E, Ferrara N, Fyfe G, Rogers B, Ross R, Kabbinavar F. Bevacizumab plus irinotecan, fluorouracil, and leucovorin for metastatic colorectal cancer. N Engl J Med. 2004 Jun 3;350(23):2335-42. doi: 10.1056/NEJMoa032691.
Hanna RM, Barsoum M, Arman F, Selamet U, Hasnain H, Kurtz I. Nephrotoxicity induced by intravitreal vascular endothelial growth factor inhibitors: emerging evidence. Kidney Int. 2019 Sep;96(3):572-580. doi: 10.1016/j.kint.2019.02.042. Epub 2019 Apr 9.
Takada H, Yamashita K, Osawa L, Komiyama Y, Nakakuki N, Muraoka M, Suzuki Y, Sato M, Takano S, Fukasawa M, Yamaguchi T, Maekawa S, Takahashi K, Uchimura K, Enomoto N. Impact of Renal Function on the Prognosis of Patients Receiving Atezolizumab/Bevacizumab Combination Therapy and Lenvatinib Monotherapy for Unresectable Hepatocellular Carcinoma. Oncology. 2023;101(10):609-623. doi: 10.1159/000531111. Epub 2023 Jun 6.
Shye M, Hanna RM, Patel SS, Tram-Tran N, Hou J, Mccannel C, Khalid M, Hanna M, Abdelnour L, Kurtz I. Worsening proteinuria and renal function after intravitreal vascular endothelial growth factor blockade for diabetic proliferative retinopathy. Clin Kidney J. 2020 Jun 28;13(6):969-980. doi: 10.1093/ckj/sfaa049. eCollection 2020 Dec.
Zhu J, Ding X, Zhang J, Chen B, You X, Chen X, Chen T. Acute kidney injury in cancer patients receiving anti-vascular endothelial growth factor monoclonal antibody vs. immune checkpoint inhibitors: a retrospective real-world study. BMC Cancer. 2024 Jun 24;24(1):756. doi: 10.1186/s12885-024-12540-y.
Other Identifiers
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KY2023-R206
Identifier Type: -
Identifier Source: org_study_id
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