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

Phase 2

Completed

• Conditions: Anal Canal Cancer; Anal Canal Cancer Stage I; Anal Canal Cancer Stage II; Anal Canal Cancer Stage III; Anal Squamous Cell Carcinoma; Anal Cancer
• Interventions: Drug: Toripalimab

• Registration Number: NCT05060471
• Lead Sponsor: Sun Yat-sen University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-19
• Study First Submitted QC: 2021-09-19
• Study First Posted: 2021-09-29
• Study Start: 2021-10-27
• Primary Completion: 2024-06-21
• Status Verified: 2024-11
• Study Completion: 2024-11-27
• Last Update Submitted: 2024-11-28
• Last Update Posted: 2024-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
cCR rate	3 months after treatment	cCR rate 3 months after treatment

Secondary Outcome Measures

Name	Time	Method
distant metastasis rate	from the end of treatment to 5 years after treatment	distant metastasis rate
progression free survival	from the end of treatment to 5 years after treatment	progression free survival
overall sruvival	from the end of treatment to 5 years after treatment	overall sruvival
acute toxicities	from the start of treatment to 3 months after treatment	acute toxicities
cCR rate	6 months after treatment	cCR rate 6 months after treatment
late toxicities	3 months after treatment	late toxicities
local recurrence rate	from the end of treatment to 5 years after treatment	local recurrence rate
colostomy rate	from the end of treatment to 2 years after treatment	colostomy rate

Trial Locations

Locations (1)

Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China