Clinical trial · Interventional
A Phase II Study of HR070803 in the Treatment of Advanced Esophageal Cancer
An Open, Single-arm, Multicenter Phase II Study of HR070803 in the Treatment of Advanced Esophageal Cancer
NCT05425472CI-TRIAL-00060683unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To evaluate the efficacy, safety and pharmacokinetic characteristics of HR070803 in the treatment of advanced esophageal cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HR070803 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HR070803
- description
- HR070803 monotherapy will be administered by intravenous infusion
- interventionNames
- Drug: HR070803
Primary outcomes (1)
- measure
- Objective response rate
- timeFrame
- for 4 months following the date the last patient was randomized
- description
- The study is designed to evaluate the objective response rate of HR070803 in patients with advanced esophageal cancer. ORR is defined as percentage of patients achieving a best response of complete response (CR) or partial response (PR) as per RECIST version 1.1.
Secondary outcomes (6)
- measure
- Progression Free Survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. ECOG performance status 0 or 1 2. Histologically confirmed advanced esophageal carcinoma 3. At least one measurable lesion is present according to the efficacy evaluation criteria for solid tumors (RECIST 1.1) 4. Able and willing to provide a written informed consent Exclusion Criteria: 1. The tumor obviously invades adjacent organs of esophageal lesions 2. BMI≤18.5 kg/m2 or weight loss ≥10% within 2 months prior to screening 3. Subjects with unresolved adverse effects of prior therapy at the time of enrolment 4. Subjects who had received anti-tumor treatments such as surgery, chemotherapy, radiotherapy recently
References
Publications (0)
Data not yet available
No reference posted for this study.