PD-1 Blockade Combined With Chemotherapy Followed by Concurrent Immunoradiotherapy for Locally Advanced SCCA Patients

Korábbi kezelés

• Received radiation therapy in abdominal or pelvic regions
• Patients with active tuberculosis (TB) are receiving anti-tuberculosis treatment or have received anti-tuberculosis treatment within 1 year before screening;
• Drug abuse and medical, psychological or social factors that may interfere with patients' participation in the study or affect the evaluation of the study;
• Received any anti-infection vaccine (e.g. influenza vaccine, chickenpox vaccine, etc.) within 4 weeks before enrollment;
• Complications require long-term treatment with immunosuppressive drugs, or requiring systemic or local use of immunosuppressive corticosteroids(>10mg/day prednisone or other therapeutic hormones);

Más betegség

• Infectious disease: Active phase chronic hepatitis B or hepatitis C (high copies of virus DNA); Other serious active clinical infection
• Chronic inflammatory colorectal disease, unrelieved ileus
• Allergic to research-related drugs
• Severe hypertension with poor drug control;
• Epilepsy require medical treatment (such as steroid or antiepileptic therapy);
• Patients have any active autoimmune diseases or a history of autoimmune diseases (including but not limited to: 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 unstable condition or which endangers the patients' safety and compliance;

Egyéb

• Diagnosed as stage I and well differentiated squamous cell carcinoma
• Distant metastasis
• Pregnant, lactating woman patient or fertile but lacks adequate contraceptives
• Dyscrasia or organ decompensation
• Refuses to sign informed consent

• (1) Histology confirmed as anal canal squamous carcinoma;
• Clinical stage I-III
• No distant metastasis;
• Age: 18-75 years old;
• ECOG 0-1 score
• Adequate bone marrow, liver, kidney function
• if HIV infected, HIV loading is below the lower limit (<20 copy </ ml), with the number of CD4+T cells > 300> ml
• Non-pregnant or lactating 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.
• No previous anal canal surgery or anal tumor resection (except for biopsy);
• No chemotherapy received within the previous 5 years;
• No previous pelvic radiation;
• No biological treatment received in the previous 5 years;
• No previous immunotherapy received.