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chemo-radiation treatment

Phase 2

Anal Canal Cancer | Unknown | Oncology |Avalon GloboCare Corp.|Last Updated: Oct 2, 2025

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment45

FDA Designations

No designations recorded

Clinical trial landscape

chemo-radiation treatment · 1 trial · 1 indication

Phase 2 1
NCT05040815Inguinal Node Sparing Radiotherapy For Patients With Early Stage Anal CancerAnal Canal Cancer
RECRUITING45 Analytics
PHASE2RECRUITING
Inguinal Node Sparing Radiotherapy For Patients With Early Stage Anal Cancer
Anal Canal CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of inguinal lymph node recurrence
Total duration of follow up is 36 months

The primary end point is measured by PET/CT imaging at 3 months post treatment and, then CT scan of chest, abdomen and pelvis every 3 months for 2 years and then every 6 months for another year.

Disease free survival (DFS)
36 months

Time between enrollment and date of relapse (radiographic or clinical progression) leading to change in therapy for recurrent disease or death due to any cause.

Secondary Endpoints

Health related Quality of Life (EORTC QLQ-C30)
36 months
Health related Quality of Life (EORTC QLQ-AN27)
36 months
Health related Quality of Life (IIEF)
36 months
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
chemo-radiation treatmentEXPERIMENTALRadiotherapy with concurrent 5-fluorouracil and mitomycin-C combination treatment. Radiotherapy consists of 5400 cGy delivered in 30 fractions over 6 weeks. The investigators will be using the current standard regimen for the study or no change in the current CCI treatment regimen. However, the radiotherapy target will be smaller than current practice since the investigators will be omitting prophylactic inguinal irradiation.

Interventions

NameTypeDescription
chemo-radiation treatmentRADIATIONRadiotherapy (RT) with concurrent 5-fluorouracil and mitomycin-C (5FU/MMC) combination is the treatment of choice for non-metastatic locally advanced anal squam
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Participants capable of giving informed consent. 2. Patients must be 18 years of age or older. 3. Patient should have histologically proven primary squamous cell carcinoma. 4. Patients must have early AC, Stage T1-3 N0 M0. 5. No inguinal nodal involvement confirmed by PET ima...

Countries:Canada
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Frequently asked questions about chemo-radiation treatment

What is chemo-radiation treatment used for in anal canal cancer?

Chemo-radiation treatment is being studied for use in anal canal cancer, specifically in patients with early stage disease. The treatment combines chemotherapy with radiation therapy, and the current clinical trial is evaluating an inguinal node sparing radiotherapy approach for these patients.

Who makes chemo-radiation treatment?

Chemo-radiation treatment is being developed by Avalon GloboCare Corp., a biopharmaceutical company. The company is conducting a Phase 2 clinical trial to evaluate this treatment approach in patients with early stage anal canal cancer.

What phase is chemo-radiation treatment in?

Chemo-radiation treatment is currently in Phase 2 clinical development. It is an investigational treatment and has not been approved by regulatory authorities. The ongoing Phase 2 trial is recruiting patients with early stage anal canal cancer to assess the safety and efficacy of this approach.

What clinical trials is chemo-radiation treatment in?

Chemo-radiation treatment is being evaluated in one active clinical trial, NCT05040815, titled 'Inguinal Node Sparing Radiotherapy For Patients With Early Stage Anal Cancer'. This Phase 2 study is recruiting 45 participants in Canada and is not randomized or blinded.

Is chemo-radiation treatment the same as inguinal node sparing radiotherapy?

Chemo-radiation treatment in this context refers to the combination of chemotherapy and radiation therapy being studied for anal canal cancer. The specific clinical trial NCT05040815 is evaluating an inguinal node sparing radiotherapy approach, which is a technique that aims to reduce radiation exposure to the inguinal lymph nodes.