Chemoradiotherapy Combined With or Without PD-1 Blockade in Anal Canal Squamous Carcinoma Patients

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Brief Title

Chemoradiotherapy Combined With or Without PD-1 Blockade in Anal Canal Squamous Carcinoma Patients

Official Title

A Phase 3, Multicenter, Double-Blind Randomized Study of Mitomycin, 5-Fluorouracil and IMRT Combined With or Without Anti-PD-1 in Patients With Locally Advanced Anal Canal Squamous Carcinoma

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).
    


Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Progression free survival

Secondary Outcome

 Acute toxicities

Condition

Anal Canal Cancer Stage III

Intervention

PD-1 inhibitor

Study Arms / Comparison Groups

 Experimental Group
Description:  Concurrent PD-1 antibody sintilimab combined with mytomicin C, 5-fluorouracil, and IMRT, followed by adjuvant sintilimab

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

102

Start Date

May 7, 2022

Completion Date

December 31, 2025

Primary Completion Date

May 31, 2025

Eligibility Criteria

        Inclusion Criteria:

          1. Histology identified anal canal squamous carcinoma,

          2. Aged 18 to 75,

          3. Clinical staging III, Eastern Cooperative Oncology Group 0-2 score,

          4. 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,

          5. No previous anal canal surgery or anal tumor resection (except for biopsy),

          6. No previous chemotherapy or pelvic radiotherapy history,

          7. 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,

          8. Adequate bone marrow, liver, and kidney function,

          9. Clinical complete response (cCR) (Chest, abdominal and pelvic enhanced CT or pelvic
             enhanced MRI or PET/CT),

         10. Informed consent assigned, Final inclusion criteria,

         11. Non-pregnant or breast-feeding women,

         12. 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,

         13. No other serious disease leading to shortened survival.

        Exclusion Criteria:

          1. Diagnosed as stage I-II 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. 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,

          6. Severe hypertension not well controlled by drugs,

          7. Active phase of chronic hepatitis B or hepatitis C (high copies of virus DNA),

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

          9. Other active clinical severe infection (NCI-CTCAE (version 4.0) ),

         10. Dyscrasia, organ dysfunction,

         11. Known or suspicious allergy to any research-related drugs,

         12. Epilepsy needs treatments (Steroid or anti-epilepsy therapy),

         13. Other malignant tumor history within 5 years,

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

         15. 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,

         16. Any anti-infection vaccine 4 weeks before inclusion,

         17. Long-term exposure to immune-suppressor, combination of systemic or topical use of
             corticosteroids (dose>10mg/day prednisolone or equivalent hormone),

         18. Any unstable state might endanger the patients' safety and compliance,

         19. Refuses to sign informed consent.
      

Gender

All

Ages

18 Years - 75 Years

Accepts Healthy Volunteers

No

Contacts

Xiang-bo Wan, PhD, +86-13826017157, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT05374252

Organization ID

E2021144


Responsible Party

Sponsor

Study Sponsor

Sixth Affiliated Hospital, Sun Yat-sen University


Study Sponsor

Xiang-bo Wan, PhD, Principal Investigator, Sun Yat-sen University


Verification Date

May 2022