a Neo-adjuvant Chemotherapy Immunotherapy in Resectable ESCC Study

A Retrospective, Multicenter, Single-arm Real-world Study on a New Adjuvant Chemotherapy Combined With Immune Inhibitors for Resectable Esophageal Squamous Cell Carcinoma (ESCC)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06472635

Acronym

ANACIIRE-1

Enrollment

Registered

2024-06-25

Start date

2022-03-01

Completion date

2024-10-31

Last updated

2024-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The Neoadjuvant Treatment for Resectable Esophageal Squamous Cell Carcinoma

Brief summary

Research Purpose 1: To evaluate the therapeutic efficacy and safety of neoadjuvant immunotherapy combined with chemotherapy in the treatment of resectable locally advanced esophageal squamous cell carcinoma (ESCC) in the real-world setting. Research Purpose 2: To analyze the influencing factors of the therapeutic effect of neoadjuvant immunotherapy combined with chemotherapy in the treatment of resectable locally advanced esophageal squamous cell carcinoma (ESCC) in the real-world setting. Research Purpose 3: To understand the treatment patterns of neoadjuvant immunotherapy combined with chemotherapy in the treatment of resectable locally advanced ESCC in the

Detailed description

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

Inclusion criteria

Age ≥ 18 years (including 18 years old); ECOG 0 or 1; Patients with esophageal squamous cell carcinoma judged to be resectable (including initially non-resectable) by the researcher Received esophageal radical surgery and neoadjuvant immune chemotherapy before surgery Clinical staging belongs to: T1b-4NanyM0;

Exclusion criteria

Patients without complete medical information; Received other anti-tumor treatment before surgery; Received radiotherapy treatment; Judged by the researcher, have other conditions unsuitable for participating in this clinical study. Hide hide Contacts/Locations

Design outcomes

Primary

Measure	Time frame	Description
Pathological Complete Response (pCR)	12 months	pCR is defined as the ratio of residual viable tumor cells being 0 in the primary tumor and sampled lymph nodes.

Secondary

Measure	Time frame	Description
Resection Rate	12 months	R0 resection refers to the complete removal of the tumor, with negative microscopic margins, indicating no residual tumor; no cancer cells are found on the cutting line under pathological examination.

Other

Measure	Time frame	Description
ORR	12 months	Defined as the proportion of patients achieving complete response (CR) or partial response (PR) among all patients, with efficacy evaluation based on the RECIST 1.1 criteria.

Countries

China

Outcome results