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Single-Arm, multicenter, phase II clinical study of neoadjuvant tirelizumab combined with albumin paclitaxel cisplatin in patients with borderline resectable esophageal squamous cell carcinoma

Single-Arm, multicenter, phase II clinical study of neoadjuvant tirelizumab combined with albumin paclitaxel cisplatin in patients with borderline resectable esophageal squamous cell carcinoma

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100051514
Enrollment
Unknown
Registered
2021-09-25
Start date
2022-01-01
Completion date
Unknown
Last updated
2022-06-20

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

Conditions

Borderline resectable esophageal cancer

Interventions

Experimental group:Tislelizumab + nab-paclitaxel + cisplatin

Sponsors

Taizhou Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Sign the informed consent; 2. Patients with diagnosed resectable or marginally resectable esophageal squamous cell carcinoma; 3. Patients with advanced disease who have not received systemic treatment before; 4. Aged 18 to 75 years; 5. The expected survival period is more than 6 months; 6. White blood cells>=4.0x10^9/l, neutrophils>=1.5x10^9/l, platelets>=100.0x10^9/l, hemoglobin>=90g/l; normal liver and kidney function; 7. ECOG PS 0~1 points.

Exclusion criteria

Exclusion criteria: 1. Patients who currently or have participated in any other anti-tumor clinical research; 2. Any previous treatment of esophageal cancer with systemic anticancer therapy as the main treatment method, including cytotoxic therapy, targeted therapy (including tyrosine kinase inhibitors or monoclonal antibodies) and immunotherapy, except for the use of neoadjuvant therapy ; 3. Patients who have received adjuvant therapy before enrollment; 4. Patients with stage III-IV esophageal cancer who do not receive the trial; 5. Female patients who are pregnant or breastfeeding; 6. Patients who are assessed by the investigator as unsuitable for enrollment, such as neurological disorders or metabolic disorders, physical examination or laboratory tests suspect the patient to have a possible disease, or have contraindications to the use of the study drug, or have treatment-related complications high risk etc.

Design outcomes

Primary

MeasureTime frame
Patient pathology assessment ;Patient imaging assessment;Evaluation standard of clinical efficacy after immunotherapy combined with chemotherapy;

Countries

China

Contacts

Public ContactShen Jianfei

Taizhou Hospital

jianfei051@163.com+86 13736284839

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 13, 2026