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DV Combined With PD-1 and Platinum-based First-line Treatment in Patients With HER2 IHC2+/3+ ESCC

NCT06055153 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-09-26

No results posted yet for this study

Summary

This is a single-arm, exploratory clinical study.

Conditions

  • Esophageal Squamous Carcinoma
  • HER-2 Protein Overexpression

Interventions

DRUG

RC48+PD-1+platinum-based

Phase I: Three subjects with HER2 overexpression (IHC 2+/3+) were initially enrolled. If dose-limiting toxicity (DLT) was observed in two of the three subjects, the study was continued from dose 1 to dose 2. If ≤1 DLT is observed in 3 subjects, continue to enroll 3 patients, and if ≤2 DLT is observed in 6 subjects, proceed to the second phase. If \> 2 cases of DLT are observed in 6 subjects, adjust to dose 2 for phase 2. Dose 1: RC48 2.5mg/kg, d1, once every 3 weeks; Camrelizumab 200mg, d1 once every 3 weeks; Platinum: Cisplatin 75mg/m2(or nedaplatin 75mg/m2), d1, once every 3 weeks Dose 2: RC48 2.0mg/kg, d1, once every 3 weeks; Camrelizumab 200mg, d1 once every 3 weeks; Platinum: Cisplatin 75mg/m2(or nedaplatin 75mg/m2), d1, once every 3 weeks The second stage: sample size expansion stage. RP2D obtained at stage 1 continues to be enrolled in up to 20 patients until disease progression or intolerable toxicity occurs.

Sponsors & Collaborators

  • Changhai Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-30
Primary Completion
2025-02-28
Completion
2025-04-30

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06055153 on ClinicalTrials.gov