Anal Carcinoma

Although NLR and PLR independently correlate with anal cancer risk, when controlling for other risk predictors, only PNI and CD4/CD8 ratio were statistically significant biomarkers for anal cancer. The CD4/CD8 ratio is the strongest immune inflammatory marker that predicts risk of anal cancer among veterans living with HIV.

P2, N=27, Enrolling by invitation, Sun Yat-sen University | Trial completion date: Dec 2023 --> Jun 2024 | Trial primary completion date: Sep 2023 --> Apr 2024

Inflammatory pathways in tissue in line with elevated levels of regulatory T-cells and CXCL2 in peripheral blood are associated with resistance to CRT. To counteract this resistance mechanism, the RADIANCE randomized phase-2 trial currently tests the addition of the immune checkpoint inhibitor durvalumab to standard CRT in locally advanced ASCC.

Our predictive model, which incorporates TMFP, has considerable accuracy in predicting pCR after nCRT in patients with locally advanced rectal cancer. This may provide a basis for more precisely selecting individualized therapy.

P1/2, N=107, Recruiting, National Cancer Institute (NCI) | Trial completion date: Dec 2024 --> Dec 2025

P1, N=90, Completed, Shanghai Bovax Biotechnology Co., Ltd. | Recruiting --> Completed | Trial completion date: Sep 2024 --> Nov 2023 | Trial primary completion date: Sep 2024 --> Nov 2023

P=N/A, N=148, Not yet recruiting, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

P=N/A, N=5000, Recruiting, University of Minnesota | Trial completion date: Mar 2024 --> Dec 2024 | Trial primary completion date: Mar 2024 --> Dec 2024

P3, N=344, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Aug 2024 --> Dec 2025 | Trial primary completion date: Aug 2024 --> Dec 2025

P1, N=24, Not yet recruiting, Corregene Biotechnology Co., Ltd

P2, N=382, Active, not recruiting, MacroGenics | N=100 --> 382 | Trial completion date: Dec 2026 --> May 2027 | Trial primary completion date: Dec 2026 --> May 2027

P=N/A, N=75, Active, not recruiting, Oslo University Hospital | Trial completion date: Jan 2024 --> Dec 2024

PWH with both aHSIL and a nadir CD4 cell count ≤200/µL have the highest risk of IAC. PWH who died due to IAC progression had clinical stage IIIA cancer or higher at diagnosis, highlighting the importance of early diagnosis through high-resolution anoscopic screening.

P1/2, N=150, Active, not recruiting, Transgene | Recruiting --> Active, not recruiting | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Dec 2023 --> Dec 2024

Despite a higher incidence of adverse events, combining atezolizumab with mDCF is feasible, with similar dose intensity in both groups, although the primary efficacy endpoint was not met. The predictive value of a PD-L1 combined positive score of 5 or greater now needs to be confirmed in future studies.

P=N/A, N=20, Not yet recruiting, Massachusetts General Hospital

P=N/A, N=200, Recruiting, European Institute of Oncology

Some glucose-lowering drugs were associated with gastrointestinal cancer risk, which might provide new ideas for gastrointestinal cancer treatment.

P=N/A, N=89, Active, not recruiting, Ohio State University Comprehensive Cancer Center | Trial completion date: Dec 2024 --> Dec 2026 | Trial primary completion date: Dec 2023 --> Oct 2023

P1, N=54, Completed, Incyte Corporation | Active, not recruiting --> Completed

P2, N=99, Active, not recruiting, GERCOR - Multidisciplinary Oncology Cooperative Group | Trial completion date: Dec 2023 --> Dec 2024

P=N/A, N=39, Active, not recruiting, University Health Network, Toronto | Trial completion date: Nov 2023 --> Dec 2024 | Trial primary completion date: Nov 2023 --> Dec 2024

P1, N=200, Active, not recruiting, SOTIO Biotech AG | Trial completion date: Dec 2023 --> Nov 2024 | Trial primary completion date: Dec 2023 --> Aug 2024

P=N/A, N=1500, Recruiting, University of California, San Francisco | N=3000 --> 1500

Worldwide, nine cases of malignancy were associated with HPV and four with EBV. Immunocompromised WHIMS patients appear to be particularly susceptible to developing early malignancy, mainly HPV-induced carcinomas, followed by EBV-related lymphomas.

CheckMate 577 evaluated nivolumab in patients who had residual pathological disease after neoadjuvant chemoradiation followed by complete resection...Stereotactic body radiation therapy followed by sorafenib was compared to sorafenib alone in patients with hepatocellular carcinoma in the NRG/RTOG 1112 study. New options in the management of rectal cancer are emerging such as total neoadjuvant treatment (PRODIGE 23, RAPIDO, PROSPECT), organ preservation (OPRA, OPERA), and the role of immunotherapy in patients with DNA mismatch-repair deficient/microsatellite instability. Finally, preliminary results of the ACT 4 trial that evaluated de-escalation in anal cancer are presented.

P1/2, N=20, Terminated, SQZ Biotechnologies | N=60 --> 20 | Trial completion date: Mar 2024 --> Nov 2023 | Active, not recruiting --> Terminated | Trial primary completion date: Mar 2024 --> Nov 2023; Corporate Decision

P1, N=5, Terminated, SQZ Biotechnologies | N=72 --> 5 | Trial completion date: Apr 2024 --> Nov 2023 | Active, not recruiting --> Terminated | Trial primary completion date: Apr 2024 --> Nov 2023; Corporate Decision

P2, N=17, Active, not recruiting, Frantz Viral Therapeutics, LLC | Recruiting --> Active, not recruiting | N=48 --> 17

P2, N=137, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Feb 2024 --> Feb 2025 | Trial primary completion date: Feb 2024 --> Feb 2025

P=N/A, N=120, Recruiting, OHSU Knight Cancer Institute | Trial completion date: Nov 2023 --> Dec 2024 | Trial primary completion date: Nov 2023 --> Dec 2024

P2, N=77, Active, not recruiting, University of Washington | Recruiting --> Active, not recruiting | N=56 --> 77

This study highlights that HR-HPV other types are more prevalent in anal ASCUS cases compared to the cervical ASCUS cases, where HR-HPV 16 is more common. Our findings support the use of concurrent cytology and HR-HPV testing for anal cancer screening. Co-testing significantly enhances the specificity of atypical cytology diagnoses, enabling more accurate patient triaging.

P=N/A, N=200, Not yet recruiting, Case Comprehensive Cancer Center

P2, N=112, Active, not recruiting, UNICANCER | Trial completion date: Oct 2024 --> Jan 2025

P=N/A, N=56, Recruiting, Case Comprehensive Cancer Center | Trial completion date: Dec 2023 --> Jul 2024 | Trial primary completion date: Dec 2023 --> Jul 2024

P=N/A, N=170, Recruiting, National Cancer Institute, Naples

symptomatic gallbladder stone diseases were significantly higher in HIV- patients; while anal cancer, anal warts, and perianal infections and perianal fistulae were significantly higher in HIV+ patients. HIV+ patients had a significantly higher mortality rate than HIV- patients, and this needs further investigation.

P1, N=32, Recruiting, HRYZ Biotech Co. | Not yet recruiting --> Recruiting

P=N/A, N=718, Completed, Medical College of Wisconsin | Active, not recruiting --> Completed

P=N/A, N=253, Completed, Medical College of Wisconsin | Active, not recruiting --> Completed

Pembrolizumab has durable efficacy in a rare subset of anal cancers. However, despite persistence of HPV infection, indicated by circulating HPV DNA, most advanced anal cancers have low numbers of tumor-associated CD8+PD-1+ T cells and are resistant to pembrolizumab.