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

• Sponsor: Sun Yat-sen University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05060471
• Collaborator: (none)
• Enrollment: 27
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 27.7
• Patients Per Site Per Month: 1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anal Canal Cancer; Anal Squamous Cell Carcinoma; Anal Cancer; Anal Canal Cancer Stage I; Anal Canal Cancer Stage II; Anal Canal Cancer Stage III	Drug: Toripalimab	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 27 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Neoadjuvant PD-1 Blockade Combined With Chemotherapy Followed by Concurrent Immunoradiotherapy for Locally Advanced Anal Canal Squamous Carcinoma Patients
• Actual Study Start Date: Sep 8, 2021
• Anticipated Primary Completion Date: Sep 30, 2023
• Anticipated Study Completion Date: Dec 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervetional group Neoadjuvant PD-1 antibody toripalimab combined with docetaxol and cisplatin, followed by radiotherapy and concurrent toripalimab	Drug: Toripalimab; Four cycles of neoadjuvant PD-1 antibody toripalimab combined with docetaxol and cisplatin, followed by radiotherapy and two cycles of concurrent toripalimab.; Other Names: radiation

Outcome Measures

Primary Outcome Measures

1. cCR rate [3 months after treatment]

   cCR rate 3 months after treatment

Secondary Outcome Measures

1. cCR rate [6 months after treatment]

   cCR rate 6 months after treatment

2. acute toxicities [from the start of treatment to 3 months after treatment]

   acute toxicities

3. late toxicities [3 months after treatment]

   late toxicities

4. colostomy rate [from the end of treatment to 2 years after treatment]

   colostomy rate

5. local recurrence rate [from the end of treatment to 5 years after treatment]

   local recurrence rate

6. distant metastasis rate [from the end of treatment to 5 years after treatment]

   distant metastasis rate

7. progression free survival [from the end of treatment to 5 years after treatment]

   progression free survival

8. overall sruvival [from the end of treatment to 5 years after treatment]

   overall sruvival

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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 </ ml), with the number of CD4+T cells > 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong	China	510060

Sponsors and Collaborators

• Sun Yat-sen University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yuan-hong Gao, Professor, Sun Yat-sen University
• ClinicalTrials.gov Identifier: NCT05060471
• Other Study ID Numbers: B2021-137-01
• First Posted: Sep 29, 2021
• Last Update Posted: Sep 29, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Anus Neoplasms

Study Results

No Results Posted as of Sep 29, 2021