Cadonilimab in Combination With Chemotherapy for Locally... | NCT05833971

Studies
Cadonilimab in Combination With Chemotherapy for Locally Advaced Esophageal Squamous Cell Carcinoma

NCT05833971

Sponsor

Guangzhou Institute of Respiratory Disease

Status

Unknown status

Last Update Posted

Apr 27, 2023Actual

Enrollment

43Estimated

Phase

Phase 2

Conditions

Resectable Esophageal Squamous Cell Carcinoma
Neoadjuvant Therapy

Interventions

cadonilimab+chemotherapy

Countries

Not provided

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

Apr 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2023Estimated

Primary Completion Date

Jun 1, 2024Estimated

Completion Date

Jun 1, 2026Estimated

First Submitted Date

Feb 25, 2023

First Submission Date that Met QC Criteria

Apr 18, 2023

First Posted Date

Apr 27, 2023Actual

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

Apr 18, 2023

Last Update Posted Date

Apr 27, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

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

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

43Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Experimental: cadonilimab (AK104) + chemotherapy	Experimental	Drug: Cadonilimab+ chemotherapy，10mg/kg IV every 3 weeks (Q3W)，Other Name: AK104； Cisplatin，60-75mg/m2 IV every 3 weeks (Q3W)，Other Name: DDP；Albumin Paclitaxel，260mg/m2 IV every 3 weeks D1, 8(Q3W)，Other Name: Nab-PTX	Drug: cadonilimab+chemotherapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
cadonilimab+chemotherapy	Drug	cadonilimab plus cisplatin and Nab-PTX, Q3W	Experimental: cadonilimab (AK104) + chemotherapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
pathologic complete response (pCR)	Analysis of prognosis efficacy of patients: pathologic complete response (pCR)	1 month after resection

Secondary Outcomes

Measure	Description	Time Frame
Radical resection (R0)		1 month after resection
Overall survival(OS)		up to 2 years
Objective response rate(ORR)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18-70 years, both men and women
Pathologically confirmed esophageal squamous cell carcinoma，and the clinic staging is cT2N1-3M0 or cT3N0-3M0 or cT4N0-3M0, TNM staging is II-IVA
Non-cervical esophageal carcinoma
Patients who have never received systemic antitumor therapy and who have measurable lesions that meet RECIST 1.1 criteria
ECOG score 0-1
Life expectancy ≥12 months
Patients with normal function organs, no serious abnormalities of blood, heart, lung, liver, kidney function, and immunodeficiency disease
For female subjects of childbearing age, they should have a negative urine or serum pregnancy test within 7 days before receiving the first study drug administration. Male and female patients need to use high-efficiency contraception during treatment until at least 8 weeks after stop the treatment
Sign the informed consent form before any trial-related procedures are implemented

Exclusion Criteria:

-Other malignancies diagnosed within 5 years prior to the first administration of the study drug, except effectively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or effectively resected in situ cervical and/or breast cancer
ulcerative esophageal squamous cell carcinoma
Esophageal or tracheal fistula
History of allergy to study drug components
History of immune disease
Patients with any serious or uncontrolled systemic disease
The presence of any adverse event (CTCAE>grade 1) caused by prior therapy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided