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

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Brief Title

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

Official Title

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

Brief Summary

      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.
    


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

cCR rate

Secondary Outcome

 cCR rate

Condition

Anal Canal Cancer

Intervention

Toripalimab

Study Arms / Comparison Groups

 Intervetional group
Description:  Neoadjuvant PD-1 antibody toripalimab combined with docetaxol and cisplatin, followed by radiotherapy and concurrent toripalimab

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

27

Start Date

September 8, 2021

Completion Date

December 30, 2023

Primary Completion Date

September 30, 2023

Eligibility Criteria

        Inclusion Criteria:

        (1) Histology confirmed as anal canal squamous carcinoma;

          1. Clinical stage I-III

          2. No distant metastasis;

          3. Age: 18-75 years old;

          4. ECOG 0-1 score

          5. Adequate bone marrow, liver, kidney function

          6. if HIV infected, HIV loading is below the lower limit (<20 copy  300> ml

          7. Non-pregnant or lactating women;

          8. 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

          9. No other serious disease leading to shortened survival.

         10. No previous anal canal surgery or anal tumor resection (except for biopsy);

         11. No chemotherapy received within the previous 5 years;

         12. No previous pelvic radiation;

         13. No biological treatment received in the previous 5 years;

         14. No previous immunotherapy received.

        Exclusion Criteria:

          1. Diagnosed as stage I and well differentiated squamous cell carcinoma

          2. Distant metastasis

          3. Received radiation therapy in abdominal or pelvic regions

          4. Pregnant, lactating woman patient or fertile but lacks adequate contraceptives

          5. Infectious disease: Active phase chronic hepatitis B or hepatitis C (high copies of
             virus DNA); Other serious active clinical infection

          6. Patients with active tuberculosis (TB) are receiving anti-tuberculosis treatment or
             have received anti-tuberculosis treatment within 1 year before screening;

          7. Chronic inflammatory colorectal disease, unrelieved ileus

          8. Dyscrasia or organ decompensation

          9. Allergic to research-related drugs

         10. Severe hypertension with poor drug control;

         11. Epilepsy require medical treatment (such as steroid or antiepileptic therapy);

         12. Drug abuse and medical, psychological or social factors that may interfere with
             patients' participation in the study or affect the evaluation of the study;

         13. 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.

         14. Received any anti-infection vaccine (e.g. influenza vaccine, chickenpox vaccine, etc.)
             within 4 weeks before enrollment;

         15. Complications require long-term treatment with immunosuppressive drugs, or requiring
             systemic or local use of immunosuppressive corticosteroids(>10mg/day prednisone or
             other therapeutic hormones);

         16. Any unstable condition or which endangers the patients' safety and compliance;

         17. Refuses to sign informed consent
      

Gender

All

Ages

18 Years - 75 Years

Accepts Healthy Volunteers

No

Contacts

, +862087343491, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT05060471

Organization ID

B2021-137-01


Responsible Party

Principal Investigator

Study Sponsor

Sun Yat-sen University


Study Sponsor

, , 


Verification Date

September 2021