Chemoradiotherapy Combined With or Without PD-1 Blockade in Anal Canal Squamous Carcinoma Patients (NCT05374252) | Clinical Trial Compass
UnknownPhase 3
Chemoradiotherapy Combined With or Without PD-1 Blockade in Anal Canal Squamous Carcinoma Patients
China102 participantsStarted 2022-05-07
Plain-language summary
This is a phase III, multi-center, double-blind randomized controlled trial assessing the efficacy and safety of concurrent mitomycin C/5-Fu chemotherapy and long-course IMRT combined with PD-1 antibody Sintilimab for locally advanced anal canal squamous carcinoma patients, by comparing an experiment group (traditional chemoradiotherapy with PD-1 antibody Sintilimab) with a control group (traditional treatment without Sintilimab).
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
✓. Clinical staging III, Eastern Cooperative Oncology Group 0-2 score,
✓. The Staging method: All patients undergoing rectal anus palpation, high resolution MRI and chest-abdominal enhanced CT, clinical data should be re-evaluated and inclusive by center evaluation group when there is contradictory staging, distant metastasis were excluded by chest-abdominal enhanced CT and pelvic enhanced MRI,
✓. No previous anal canal surgery or anal tumor resection (except for biopsy),
✓. No previous chemotherapy or pelvic radiotherapy history,
✓. No biopharmaceutical treatment history (such as monoclonal antibody), immunotherapy (such as anti PD-1antibody, anti PD-L1 antibody, anti PD-L2 antibody or anti CTLA-4), or other research drug treatment in the previous 5 years,
✓. Adequate bone marrow, liver, and kidney function,
Exclusion criteria
✕. Diagnosed as stage I-II and well differentiated squamous cell carcinoma,
✕. Distant metastasis,
✕. Received radiation therapy in abdominal or pelvic regions,
✕. Pregnant, lactating woman patient or fertile but lacks adequate contraceptives,
What they're measuring
1
Progression free survival
Timeframe: from the end of treatment to 3 years after treatment
2
Overall survival
Timeframe: from the end of treatment to 3 years after treatment
3
cCR rate
Timeframe: 6 months after treatment
Trial details
NCT IDNCT05374252
SponsorSixth Affiliated Hospital, Sun Yat-sen University
✕. Arrhythmia need anti-arrhythmia treatment (except β-blocking agent or Digoxin), symptomatic coronary heart disease or myocardial ischemia (myocardial infarction within 6 months) or congestive heart-failure (CHF) \> New York Heart Association grade II,
✕. Severe hypertension not well controlled by drugs,
✕. Active phase of chronic hepatitis B or hepatitis C (high copies of virus DNA),
✕. Patients with active tuberculosis (TB) are receiving anti-tuberculosis treatment or have received anti-tuberculosis treatment within 1 year before screening,