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New treatment option for Anal Squamous Cell Cancer
Official title Chemoradiotherapy and Anti-PD-1 Antibody in Anal Squamous Cell Cancer：Chase
ClinicalTrials.gov ID: NCT07555678
What this study is testing
What is PD-1 Inhibitor + Chemotherapy?
PD-1 Inhibitor + Chemotherapy is an investigational medicine, being studied as a potential treatment for anal squamous cell cancer.
Also referred to as radiotherapy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Squamous cell carcinoma (SCC) of the anus is a rare malignancy. For localized anal squamous cell carcinoma , definitive chemoradiotherapy is the standard treatment.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- This study consists of four cohorts. Inclusion and
You likely can't join if
- comprise general inclusion criteria, cohort-specific inclusion criteria, general exclusion criteria, and cohort-specific exclusion criteria.
- General Inclusion Criteria Age 18-75 years, male or female; Pathologically confirmed squamous cell carcinoma of the anal canal or perianal region...
- Inclusion Criteria for Cohort 1 In addition to the general inclusion criteria:（1）Tumor \< 5 cm (T1-2) and negative regional lymph nodes (N-) on...
- Inclusion Criteria for Cohort 2 In addition to the general inclusion criteria:(1) No residual tumor detectable on physical examination or imaging...
- Inclusion Criteria for Cohort 3 In addition to the general inclusion criteria:(1) Tumor ≥ 5 cm (T3), or invasion of adjacent organs (T4), or regional...
- Inclusion Criteria for Cohort 4 In addition to the general inclusion criteria:(1) Initial distant metastasis (M1) (liver, lung, bone, distant lymph...
See the full eligibility criteria
- This study consists of four cohorts. Inclusion and
- comprise general inclusion criteria, cohort-specific inclusion criteria, general exclusion criteria, and cohort-specific exclusion criteria.
- General Inclusion Criteria Age 18-75 years, male or female; Pathologically confirmed squamous cell carcinoma of the anal canal or perianal region; ECOG performance status 0-1 and life expectancy ≥ 3 months; Adequate...
- Inclusion Criteria for Cohort 1 In addition to the general inclusion criteria:（1）Tumor \< 5 cm (T1-2) and negative regional lymph nodes (N-) on physical examination or contrast-enhanced pelvic MRI;(2) No prior...
- Inclusion Criteria for Cohort 2 In addition to the general inclusion criteria:(1) No residual tumor detectable on physical examination or imaging after local excision;(2) No prior anti-tumor therapy including...
- Inclusion Criteria for Cohort 3 In addition to the general inclusion criteria:(1) Tumor ≥ 5 cm (T3), or invasion of adjacent organs (T4), or regional lymph node positivity (N+) in mesorectal, presacral...
- Inclusion Criteria for Cohort 4 In addition to the general inclusion criteria:(1) Initial distant metastasis (M1) (liver, lung, bone, distant lymph nodes, etc.) confirmed by chest/abdominal CT or PET-CT,or pelvic...
- Exclusion Criteria:
- Patients with any of the following criteria are ineligible for this study:
- Pathological diagnosis of other anal tumors, such as gastrointestinal stromal tumor, lymphoma, melanoma, etc.; Prior treatment with anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies; Previous or concurrent malignancy...
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.