PD-1 Blockade Combined with Chemotherapy Followed by Concurrent Immunoradiotherapy for Locally Advanced SCCA Patients
NCT ID: NCT05060471
Last Updated: 2024-12-03
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE2
Total Enrollment
25 participants
Study Classification
INTERVENTIONAL
Study Start Date
2021-10-27
Study Completion Date
2024-11-27
Brief Summary
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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
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Conditions
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Anal Canal Cancer
Anal Squamous Cell Carcinoma
Anal Cancer
Anal Canal Cancer Stage I
Anal Canal Cancer Stage II
Anal Canal Cancer Stage III
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Intervetional group
Neoadjuvant PD-1 antibody toripalimab combined with docetaxol and cisplatin, followed by radiotherapy and concurrent toripalimab
Group Type
EXPERIMENTAL
Toripalimab
Intervention Type
DRUG
Four cycles of neoadjuvant PD-1 antibody toripalimab combined with docetaxol and cisplatin, followed by radiotherapy and two cycles of concurrent toripalimab.
Interventions
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Toripalimab
Four cycles of neoadjuvant PD-1 antibody toripalimab combined with docetaxol and cisplatin, followed by radiotherapy and two cycles of concurrent toripalimab.
Intervention Type
DRUG
Other Intervention Names
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radiation
Eligibility Criteria
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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.
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
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
Minimum Eligible Age
18 Years
Maximum Eligible Age
75 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Sun Yat-sen University
OTHER
Sponsor Role
lead
Responsible Party
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Yuan-hong Gao
Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Locations
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Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Site Status
Countries
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China
References
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Other Identifiers
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B2021-137-01
Identifier Type: -
Identifier Source: org_study_id