Chemoradiotherapy Combined With or Without PD-1 Blockade in Anal Canal Squamous Carcinoma Patients
Phase 3
Recruiting
- Conditions
- Anal Canal Cancer Stage IIIAnal Squamous Cell CarcinomaAnal Canal CancerAnal Cancer
- Interventions
- Drug: PD-1 inhibitorRadiation: concurrent chemoradiotherapy
- Registration Number
- NCT05374252
- Lead Sponsor
- Sixth Affiliated Hospital, Sun Yat-sen University
- Brief 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 102
Inclusion Criteria
- Histology identified anal canal squamous carcinoma,
- Aged 18 to 75,
- 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,
- Clinical complete response (cCR) (Chest, abdominal and pelvic enhanced CT or pelvic enhanced MRI or PET/CT),
- Informed consent assigned, Final inclusion criteria,
- Non-pregnant or breast-feeding women,
- No other malignant disease within 5 years before diagnosis of anal cancer squamous carcinoma (except endocervical cancer in situ or skin basal cell carcinoma which had been cured); no other malignant disease beside anal cancer squamous carcinoma,
- No other serious disease leading to shortened survival.
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,
- 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,
- Other active clinical severe infection (NCI-CTCAE (version 4.0) ),
- Dyscrasia, organ dysfunction,
- Known or suspicious allergy to any research-related drugs,
- Epilepsy needs treatments (Steroid or anti-epilepsy therapy),
- Other malignant tumor history within 5 years,
- Drug abuse and medical, psychological, or social factors that may interfere with patients' participation in the study or affect the evaluation of the study,
- Patients have any active autoimmune diseases or a history of autoimmune diseases (including but not restricted: interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, nephritis, hyperthyroidism and decreased thyroid function; patients with vitiligo or with complete remission of asthma in childhood and without any intervention in adulthood may be included; patients with asthma requiring bronchodilators intervention are not included,
- Any anti-infection vaccine 4 weeks before inclusion,
- Long-term exposure to immune-suppressor, combination of systemic or topical use of corticosteroids (dose>10mg/day prednisolone or equivalent hormone),
- Any unstable state might endanger the patients' safety and compliance,
- Refuses to sign informed consent.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental Group PD-1 inhibitor Concurrent PD-1 antibody sintilimab combined with mytomicin C, 5-fluorouracil, and IMRT, followed by adjuvant sintilimab Control Group concurrent chemoradiotherapy Concurrent mytomicin C and 5-fluorouracil combined with IMRT
- Primary Outcome Measures
Name Time Method Progression free survival from the end of treatment to 3 years after treatment progression free survival
Overall survival from the end of treatment to 3 years after treatment overall survival
cCR rate 6 months after treatment cCR rate 6 months after treatment
- Secondary Outcome Measures
Name Time Method Acute toxicities from the start of treatment to 3 months after treatment acute toxicities according to the NCI CTCAE (version 4.0)
Colostomy rate 2 year colostomy rate
Local recurrence rate from the end of treatment to 3 years after treatment local recurrence rate
Distant metastasis rate from the end of treatment to 3 years after treatment distant metastasis rate
cCR rate 3 months after treatment cCR rate 3 months after treatment
The rate of late toxicity according to the RTOG/EORTC scale 3 years The rate of late toxicity according to the RTOG/EORTC scale
Incidence rate of Grade ≥3 PD-1monoclonal antibody-related adverse events 1 year Incidence rate of Grade ≥3 PD-1monoclonal antibody-related adverse events
Trial Locations
- Locations (1)
The Sixth Affiliated Hospital of Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China