Neoadjuvant PD-1 Blockade Combined With Chemotherapy Followed by Concurrent Immunoradiotherapy for Locally Advanced Anal Canal Squamous Carcinoma Patients

Study Overview
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Brief Summary
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Locally Advanced Anal Canal Squamous Carcinoma Patients will be enrolled and given four cycles of neoadjuvant PD-1 antibody toripalimab combined with docetaxol and cisplatin, followed by radiotherapy and two cycles of concurrent toripalimab. Treatment outcomes and toxicities will be evaluated.

Official Title
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Neoadjuvant PD-1 Blockade Combined With Chemotherapy Followed by Concurrent Immunoradiotherapy for Locally Advanced Anal Canal Squamous Carcinoma Patients

Conditions
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Anal Canal Cancer, Anal Squamous Cell Carcinoma, Anal Cancer, Anal Canal Cancer Stage I, Anal Canal Cancer Stage II, Anal Canal Cancer Stage III

Intervention / Treatment
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* Drug: Toripalimab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: (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. Exclusion Criteria: Diagnosed as stage I 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 Infectious disease: Active phase chronic hepatitis B or hepatitis C (high copies of virus DNA); Other serious active clinical infection Patients with active tuberculosis (TB) are receiving anti-tuberculosis treatment or have received anti-tuberculosis treatment within 1 year before screening; Chronic inflammatory colorectal disease, unrelieved ileus Dyscrasia or organ decompensation Allergic to research-related drugs Severe hypertension with poor drug control; Epilepsy require medical treatment (such as steroid or antiepileptic therapy); 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 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. 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); Any unstable condition or which endangers the patients' safety and compliance; Refuses to sign informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervetional group<br>Neoadjuvant PD-1 antibody toripalimab combined with docetaxol and cisplatin, followed by radiotherapy and concurrent toripalimab | Drug: Toripalimab<br>* Four cycles of neoadjuvant PD-1 antibody toripalimab combined with docetaxol and cisplatin, followed by radiotherapy and two cycles of concurrent toripalimab.<br>* Other names: radiation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cCR rate | cCR rate 3 months after treatment | 3 months after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cCR rate | cCR rate 6 months after treatment | 6 months after treatment | 
| acute toxicities | acute toxicities | from the start of treatment to 3 months after treatment | 
| late toxicities | late toxicities | 3 months after treatment | 
| colostomy rate | colostomy rate | from the end of treatment to 2 years after treatment | 
| local recurrence rate | local recurrence rate | from the end of treatment to 5 years after treatment | 
| distant metastasis rate | distant metastasis rate | from the end of treatment to 5 years after treatment | 
| progression free survival | progression free survival | from the end of treatment to 5 years after treatment | 
| overall sruvival | overall sruvival | from the end of treatment to 5 years after treatment |