NCRT Combined With Sequential Perioperative PD-1 Inhibito... | NCT06762158

Studies
NCRT Combined With Sequential Perioperative PD-1 Inhibitor for LAESCC

NCT06762158

Sponsor

RenJi Hospital

Status

Active, not recruiting

Last Update Posted

Jan 7, 2025Actual

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Esophageal Squamous Cell Carcinoma (ESCC)

Interventions

Neoadjuvant Chemoradiotherapy
neoadjuvant immunotherapy
Surgery
adjuvant immunotherapy

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2024

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 30, 2024Actual

Primary Completion Date

Dec 1, 2027Estimated

Completion Date

Dec 1, 2029Estimated

First Submitted Date

Dec 22, 2024

First Submission Date that Met QC Criteria

Dec 31, 2024

First Posted Date

Jan 7, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 31, 2024

Last Update Posted Date

Jan 7, 2025Actual

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Perioperative toripalimab	Experimental	neoadjuvant chemoradiotherapy and perioperative toripalimab	Radiation: Neoadjuvant Chemoradiotherapy Drug: neoadjuvant immunotherapy Procedure: Surgery Drug: adjuvant immunotherapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Neoadjuvant Chemoradiotherapy	Radiation	Neoadjuvant chemoradiotherapy: Radiation dose: 1.8Gy/Fx, DT41.4Gy/23Fx. Concurrent chemotherapy: Albumin-bound paclitaxel 60mg/m² + Cisplatin 25mg/m² on D1, D8, D15, D22, D29.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
pathologically complete response(pCR)	absence of viable tumor cells in the resected cancer specimen（ypT0N0）	From date of surgery to 4 weeks later

Secondary Outcomes

Measure	Description	Time Frame
event free survival	From date of treatment until the date of death from any cause or the date of disease progression, assessed up to 24 months.	24 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18-75 years old
Histologically or cytologically confirmed esophageal squamous cell cancer
Stage T3-4aN0M0 or TanyN1-3M0 according to the American Joint Committee on Cancer staging manual eighth edition
Eastern Cooperative Oncology Group performance status of 0 or 1
he indexes of hematology, biochemistry and organ function meet the following requirements: a. white blood cell count (WBC) ≥ 3.0×109/L；b. neutrophil count (ANC) ≥ 1.5×109/L; c. platelets ≥ 85×109/L; d. hemoglobin ≥ 90g/L; e. total bilirubin ≤ 1.5 ULN; f. ALT ≤ 1.5 ULN; g. creatinine clearance rate >60 mL/min;
The cardiopulmonary function needs to meet the following criteria: EF ≥ 55%, VC > 60%, FEV1 > 1.2L, FEV1%> 40%, DLco > 40%
Women of childbearing age must undergo a pregnancy test within 7 days before enrollment for treatment, and only those with a negative result can be enrolled
Voluntarily participating in this study

Exclusion Criteria:

Patients with active infection within 2 weeks before the first use of the study drug
A history of interstitial lung disease or non-infectious pneumonia
A history of autoimmune diseases or abnormal immune system
Patients who cannot tolerate chemoradiotherapy or surgery due to severe cardiac, lung dysfunction
Patients diagnosed with any other malignant tumor within 5 years before enrollment, except for malignant tumors with low risk of recurrence and risk of death, such as fully treated basal cell or squamous cell skin and carcinoma in situ of the cervix;
Known or suspected allergy or hypersensitivity to monoclonal antibodies, any ingredients of Toripalimab, and the chemotherapeutic drugs nab-paclitaxel or cisplatin
A history of immunodeficiency，including a positive HIV test result or other acquired or congenital immunodeficiency diseases, a history of organ transplantation or allogeneic bone marrow transplantation
Women during pregnancy or lactation
Other situations not suitable for enrollment

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D002294	Carcinoma, Squamous Cell
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type

ID	Term
D020360	Neoadjuvant Therapy
D013514	Surgical Procedures, Operative

ID	Term
D003131	Combined Modality Therapy
D013812	Therapeutics