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

NCT05060471 | Completed Phase 2 DMC

• 1 other identifier: B2021-137-01
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Anal Canal Cancer; Anal Squamous Cell Carcinoma; Anal Cancer; Anal Canal Cancer Stage I; Anal Canal Cancer Stage II; Anal Canal Cancer Stage III

Outcome Measures

Primary Outcomes (1)

• cCR rate

  cCR rate 3 months after treatment

  3 months after treatment

Secondary Outcomes (8)

• cCR rate

  6 months after treatment

• acute toxicities

  from the start of treatment to 3 months after treatment

• late toxicities

  3 months after treatment

• colostomy rate

  from the end of treatment to 2 years after treatment

• local recurrence rate

  from the end of treatment to 5 years after treatment

Study Arms (1)

Intervetional group

EXPERIMENTAL

Neoadjuvant PD-1 antibody toripalimab combined with docetaxol and cisplatin, followed by radiotherapy and concurrent toripalimab

Drug: Toripalimab

Interventions

Toripalimab DRUG

Four cycles of neoadjuvant PD-1 antibody toripalimab combined with docetaxol and cisplatin, followed by radiotherapy and two cycles of concurrent toripalimab.

Also known as: radiation

Intervetional group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• 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;
• Chronic inflammatory colorectal disease, unrelieved ileus
• Dyscrasia or organ decompensation
• Allergic to research-related drugs
• Severe hypertension with poor drug control;
• Epilepsy require medical treatment (such as steroid or antiepileptic therapy);
• Drug abuse and medical, psychological or social factors that may interfere with patients' participation in the study or affect the evaluation of the study;
• 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.
• 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);

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

Related Publications (24)

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MeSH Terms

Conditions

Anal Canal Carcinoma; Anus Neoplasms

Interventions

toripalimab; Radiation

Condition Hierarchy (Ancestors)

Rectal Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Anus Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Physical Phenomena

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 19, 2021
• First Posted: September 29, 2021
• Study Start: October 27, 2021
• Primary Completion: June 21, 2024
• Study Completion: November 27, 2024
• Last Updated: December 3, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: After publication of study results.

Locations

CN (1)