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NCT05060471CompletedPhase 2

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

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

Source: ClinicalTrials.gov · Last updated 3 Dec 2024

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
25 (actual)
First submitted
19 Sept 2021
Start date
27 Oct 2021
Primary completion date
21 Jun 2024
Lead sponsor
Sun Yat-sen University
NCT number
NCT05060471

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 25
  • From 27 Oct 2021 to the primary completion date, 21 Jun 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Received radiation therapy in abdominal or pelvic regions
  • Patients with active tuberculosis (TB) are receiving anti-tuberculosis treatment or have received anti-tuberculosis treatment within 1 year before screening;
  • Drug abuse and medical, psychological or social factors that may interfere with patients' participation in the study or affect the evaluation of the study;
  • Received any anti-infection vaccine (e.g. influenza vaccine, chickenpox vaccine, etc.) within 4 weeks before enrollment;
  • Complications require long-term treatment with immunosuppressive drugs, or requiring systemic or local use of immunosuppressive corticosteroids(\>10mg/day prednisone or other therapeutic hormones);

Other illness

  • Infectious disease: Active phase chronic hepatitis B or hepatitis C (high copies of virus DNA); Other serious active clinical infection
  • Chronic inflammatory colorectal disease, unrelieved ileus
  • Allergic to research-related drugs
  • Severe hypertension with poor drug control;
  • Epilepsy require medical treatment (such as steroid or antiepileptic therapy);
  • 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.
  • Any unstable condition or which endangers the patients' safety and compliance;

Other

  • Diagnosed as stage I and well differentiated squamous cell carcinoma
  • Distant metastasis
  • Pregnant, lactating woman patient or fertile but lacks adequate contraceptives
  • Dyscrasia or organ decompensation
  • Refuses to sign informed consent

Who the study is looking for

  • (1) Histology confirmed as anal canal squamous carcinoma;
  • 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
  • No other serious disease leading to shortened survival.
  • No previous anal canal surgery or anal tumor resection (except for biopsy);
  • No chemotherapy received within the previous 5 years;
  • No previous pelvic radiation;
  • No biological treatment received in the previous 5 years;
  • No previous immunotherapy received.

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Sun Yat-sen University Cancer Center
Coordinator of this site? Confirm its status
GuangzhouChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.