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

Anal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05060471
• Other study ID #: B2021-137-01
• Status: Enrolling by invitation
• Phase: Phase 2
• Start date: September 8, 2021
• Est. completion date: June 30, 2024

Study information

• Verified date: April 2024
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 27
• Est. completion date: June 30, 2024
• Est. primary completion date: April 22, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Anal Canal Cancer
• Anal Cancer
• Anal Squamous Cell Carcinoma
• Anus Neoplasms
• Carcinoma

Intervention

Drug:
• Toripalimab
Four cycles of neoadjuvant PD-1 antibody toripalimab combined with docetaxol and cisplatin, followed by radiotherapy and two cycles of concurrent toripalimab.

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (24)

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* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cCR rate	cCR rate 3 months after treatment	3 months after treatment
Secondary	cCR rate	cCR rate 6 months after treatment	6 months after treatment
Secondary	acute toxicities	acute toxicities	from the start of treatment to 3 months after treatment
Secondary	late toxicities	late toxicities	3 months after treatment
Secondary	colostomy rate	colostomy rate	from the end of treatment to 2 years after treatment
Secondary	local recurrence rate	local recurrence rate	from the end of treatment to 5 years after treatment
Secondary	distant metastasis rate	distant metastasis rate	from the end of treatment to 5 years after treatment
Secondary	progression free survival	progression free survival	from the end of treatment to 5 years after treatment
Secondary	overall sruvival	overall sruvival	from the end of treatment to 5 years after treatment