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

November 28, 2024 updated by: Yuan-hong Gao, Sun Yat-sen University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Sun Yat-sen University Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervetional group
Neoadjuvant PD-1 antibody toripalimab combined with docetaxol and cisplatin, followed by radiotherapy and concurrent toripalimab
Drug: Toripalimab
Four cycles of neoadjuvant PD-1 antibody toripalimab combined with docetaxol and cisplatin, followed by radiotherapy and two cycles of concurrent toripalimab.
Other Names:
  • radiation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cCR rate
Time Frame: 3 months after treatment
cCR rate 3 months after treatment
3 months after treatment

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 27, 2021

Primary Completion (Actual)

June 21, 2024

Study Completion (Actual)

November 27, 2024

Study Registration Dates

First Submitted

September 19, 2021

First Submitted That Met QC Criteria

September 19, 2021

First Posted (Actual)

September 29, 2021

Study Record Updates

Last Update Posted (Actual)

December 3, 2024

Last Update Submitted That Met QC Criteria

November 28, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B2021-137-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Study data can be shared after publication of the study results, upon request.

IPD Sharing Time Frame

After publication of study results.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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