Anal cancer is rare, accounting for about 2% of digestive tract cancers. Most cases are linked to human papillomavirus (HPV) infection. Standard treatment combines chemotherapy and radiation, which cures about 80% of people when caught early. Research now focuses on reducing treatment side effects and finding better options when cancer returns.
What's actually going on in research
Trials are testing immunotherapy drugs like nivolumab and pembrolizumab, which have shown promise in HPV-related cancers. Researchers are studying whether adding immunotherapy to standard chemoradiation improves cure rates, and whether some people can skip radiation entirely. Studies also examine targeted therapies and ways to preserve bowel and sexual function during treatment.
Immunotherapy combinations
Checkpoint inhibitors that work in other HPV cancers are now being tested with chemotherapy and radiation for anal cancer. Early studies suggest they may help people whose cancer has spread or returned after initial treatment.
Treatment de-escalation
Some trials are testing whether people with small, early-stage tumors can be treated with less radiation or chemotherapy. The goal is to maintain cure rates while reducing long-term bowel, bladder, and sexual side effects.
What to know before you search
Eligibility typically depends on cancer stage, whether it has spread, prior treatments received, HPV status, and overall health.
What types of trials are currently open
- Chemoradiation trials — Testing modifications to standard chemotherapy-plus-radiation treatment, including different drug combinations or radiation doses.
- Immunotherapy trials — Studies of checkpoint inhibitors like pembrolizumab, either alone or added to chemotherapy and radiation.
- Recurrent disease trials — Testing new treatments for cancer that returns after initial therapy, often focusing on immunotherapy or targeted drugs.
- Quality of life studies — Research on managing treatment side effects and preserving bowel, sexual, and urinary function.
- Prevention studies — Following people at high risk to understand HPV's role and test strategies to prevent anal cancer from developing.
Recently added Anal Cancer trials
Evaluation of the Ileo-anal Pouch in FAP (ENDOPOL)
This international, multi-centre randomised controlled trial will compare dye-based chromoendoscopy with virtual chromoendoscopy, using NBI/BLI, for adenoma detection during routine surveillance pouchoscopy in adults with familial adenomatous polyposis (FAP) and an ileal pouch-anal anastomosis (IPAA). The estimated study duration is 2 years. Participants will undergo their usual scheduled pouchoscopy, performed by endoscopists experienced in FAP. Before the procedure, they will be randomised 1:1 to dye-based or virtual chromoendoscopy. Adenomas requiring endoscopic treatment will be removed during the same procedure according to standard practice. To our knowledge, no previous study has directly compared these techniques in this setting. Current guidelines recommend surveillance in patients with FAP and a pouch and permit dye-spray chromoendoscopy, but do not specify whether dye-based or virtual chromoendoscopy should be preferred. Practice varies between centres: virtual chromoendoscopy is commonly used at St Mark's Hospital, while some European centres primarily use dye-based chromoendoscopy. This study therefore aims to standardise practice and generate evidence to inform future surveillance strategies. Eligible patients will be adults aged ≥18 years with FAP, defined by a proven APC germline mutation or a clinical diagnosis of \>100 colorectal adenomas with a positive family history, and who have undergone IPAA after primary proctocolectomy or secondary proctectomy following IRA/ISA. Patients will be identified through routine endoscopy booking systems. Those who have consented to email communication from the Polyposis Registry team will receive a Participant Information Sheet in advance. They will be approached again on the day of their procedure, given the opportunity to ask questions, and consented before randomisation. Patients who do not consent will undergo their planned pouchoscopy as normal, without study randomisation. Patients lacking capacity to consent will not be approached. Randomisation will be performed using an independent computer-generated programme within Castor EDC, with allocation in a 1:1 ratio. Block randomisation will ensure balanced distribution between arms within each centre, and stratification by centre will account for differences in patient characteristics and local practice. Blinding is not feasible because dye-based and virtual chromoendoscopy have visually distinct appearances. During pouchoscopy, the pre-pouch ileum, pouch body and rectal cuff will be carefully inspected. In the dye-based arm, indigo carmine will be applied using a spray catheter before withdrawal and mucosal inspection. In the virtual chromoendoscopy arm, inspection will be performed using NBI/BLI according to local platform availability. The endoscope will be advanced to the pre-pouch ileum, followed by systematic withdrawal and spiral mucosal inspection. Lesions will be documented by size and location, including pouch body and rectal remnant/rectal cuff, using a polyp burden scoring table. Retroflexion will be performed to assess the rectal cuff. Polyp size will be estimated in millimetres, supported where appropriate by biopsy forceps of known size. Adenomas will be resected using standard polypectomy techniques where indicated, including polyps \>5 mm in the pouch body, \>2 mm in the rectal cuff, or lesions suspicious for high-grade dysplasia or early cancer. Because assessment of small polyps can vary between endoscopists, particularly for lesions \<5 mm, endoscopic images will be used to assess inter-rater and intra-rater reliability for polyp burden and size. If reliability is acceptable, smaller polyps will be included and reported. Quality parameters will be collected for each procedure, including adjusted Boston Bowel Preparation Scale assessment for the pouch and total procedural time. Procedural time will include scope introduction, irrigation, dye application where applicable, withdrawal and inspection, retroflexion, and removal and retrieval of polyps. Post-procedure follow-up will follow routine care. Patients will be asked to monitor for adverse events after pouchoscopy and contact the hospital if needed. Future surveillance will be scheduled according to each centre's usual policy. Study data will be held in routine hospital systems accessible to the patient's usual clinical team and in a study file. Participants will be assigned a study number. No identifiable patient information will leave the Trust or be accessible to anyone outside the usual care team. Anonymised data will be entered into Castor EDC. Pseudonymised data will be transferred to the central study team at Amsterdam University Medical Center under an existing data transfer agreement for pooled analysis. The study does not expose participants to risks beyond routine surveillance pouchoscopy. There is no direct individual benefit but findings may benefit future patients with FAP and families by improving evidence.
Take an immune therapy combined with radiation for anal cancer
This is a prospective, multicenter, open-label, phase III randomized controlled clinical trial designed to evaluate the efficacy and safety of replacing the traditional chemotherapeutic drug mitomycin with the PD-1 inhibitor sintilimab in definitive chemoradiotherapy for limited-stage anal squamous cell carcinoma. The study plans to enroll 350 previously untreated patients with limited-stage anal squamous cell carcinoma and randomize them in a 1:1 ratio into two groups: the control group will receive the current standard treatment, namely intensity-modulated radiotherapy (IMRT) concurrent with capecitabine and mitomycin; the experimental group will receive an innovative "immunotherapy replacement" regimen, namely IMRT of the same technique concurrent with capecitabine and sintilimab. The study adopts a dual primary endpoint design, aiming to verify that the experimental group is non-inferior to the control group in the clinical complete response rate at 6 months after radiotherapy, and is significantly superior to the control group in the incidence of grade 3 or higher treatment-related acute toxicities.
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