PD-1 Blockade Combined With Chemotherapy Followed by Concurrent Immunoradiotherapy for Locally Ad… (NCT05060471) | Clinical Trial Compass
CompletedPhase 2
PD-1 Blockade Combined With Chemotherapy Followed by Concurrent Immunoradiotherapy for Locally Advanced SCCA Patients
China25 participantsStarted 2021-10-27
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Clinical stage I-III
✓. No distant metastasis;
✓. Age: 18-75 years old;
✓. ECOG 0-1 score
✓. Adequate bone marrow, liver, kidney function
✓. if HIV infected, HIV loading is below the lower limit (\<20 copy \</ ml), with the number of CD4+T cells \> 300\> ml
✓. Non-pregnant or lactating women;
✓. 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
Exclusion criteria
✕. Diagnosed as stage I and well differentiated squamous cell carcinoma
✕. Distant metastasis
✕. Received radiation therapy in abdominal or pelvic regions
✕. Pregnant, lactating woman patient or fertile but lacks adequate contraceptives
✕. Infectious disease: Active phase chronic hepatitis B or hepatitis C (high copies of virus DNA); Other serious active clinical infection
. Patients with active tuberculosis (TB) are receiving anti-tuberculosis treatment or have received anti-tuberculosis treatment within 1 year before screening;