Anal Squamous Cell Cancer
Conditions
Keywords
Anal Squamous Cell Cancer, immunotherapy, chemoradiotherapy
Brief summary
Squamous cell carcinoma (SCC) of the anus is a rare malignancy. For localized anal squamous cell carcinoma , definitive chemoradiotherapy is the standard treatment. Patients who do not achieve complete response （CR）or experience recurrence require radical surgery with permanent colostomy. In previous studies of anal squamous cell carcinoma （ASCC）, although favorable response rates were achieved after concurrent chemoradiotherapy, high rates of local recurrence and distant metastasis were also observed in patients with locally advanced disease, which adversely affect patient survival. Clinical studies have demonstrated that single-agent PD-1/PD-L1 inhibitors, including nivolumab and pembrolizumab, show promising efficacy in advanced anal squamous cell carcinoma. Given the high recurrence rate associated with current concurrent chemoradiotherapy regimens and the characteristics of the immune microenvironment in anal cancer, the combination of immunotherapy with concurrent chemoradiotherapy is expected to improve therapeutic outcomes. Therefore, we designed this prospective, multicenter, phase II clinical study to investigate the efficacy and safety of concurrent chemoradiotherapy combined with immune checkpoint inhibitors in anal cancer. This study aims to enhance the therapeutic effect for patients with locally advanced, recurrent, or metastatic anal squamous cell carcinoma and reduce adverse events in patients with high-risk factors after local excision or in early-stage disease. The primary endpoints are local tumor control rate, overall survival, and radiation-related toxicity. The results will provide evidence for subsequent randomized controlled trials.
Interventions
chemotherapy and sintilimab
Sponsors
Fudan University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
chemoradiotherapy combined with immune checkpoint inhibitors in anal cancer.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
This study consists of four cohorts. Inclusion and
Exclusion criteria
comprise general inclusion criteria, cohort-specific inclusion criteria, general
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete response rate | 1 month after the surgery or the decision of Watch and wait | the primary endpoint of cohort 3 is CR rate including cCR and pCR |
| Severe acute toxicity. | from the start of radiotherapy to 3 months after the start of radiotherapy | The primary endpoint for Cohort 1 (early anal squamous cell carcinoma) and Cohort 2 (post-local excision anal squamous cell carcinoma) is the rate of severe adverse events. |
| 12-month progression-free survival (PFS). | The proportion of patients who were alive and progression-free from the start of initial treatment up to 12 months. | The primary endpoint for Cohort 4 (recurrent or metastetic anal squamous cell carcinoma) is 12-month progression-free survival (PFS). |
Countries
China
Outcome results
None listed