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An exploratory clinical study on the efficacy and safety of tirelizumab combined with gemcitabine and albumin paclitaxel in the treatment of borderline resectable pancreatic cancer

None

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200063680
Enrollment
Unknown
Registered
2022-09-14
Start date
2022-09-14
Completion date
Unknown
Last updated
2023-04-17

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

Conditions

Pancreatic cancer

Interventions

single arm:Treatment programs

Sponsors

The Second Affiliated Hospital of the Army Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) Age 18-75 years old, male or female; 2) ECoG PS score = 2; 3) Pancreatic cancer confirmed by histology or cytology has not been treated with anti-tumor radiotherapy, chemotherapy or immunotherapy in the past. 4) According to AJCC 8th Edition, it is diagnosed as potentially resectable in combination with endoscopic ultrasound or enhanced CT / MRI scanning. 5) Agree to provide blood samples and histological samples. 6) At least one measurable lesion (recist1.1) 7) No other local treatment or systematic treatment has been carried out in the past; 8) No other systemic malignancies; 9) The organ function is normal, and the following conditions are met: neutrophils = 1500/ µ L; Platelet = 60000/ µ L; Hemoglobin > 8.5 g/dl; Plasma albumin > 3.0 g/dl; Total bilirubin < 30mmol/l; ALT and AST are lower than 5 times the upper limit of normal; INR < 1.7 or PT extension not more than 4 seconds; Blood creatinine is lower than 1.5 times the upper limit of normal. The patient knew the condition and signed the written informed consent.

Exclusion criteria

Exclusion criteria: 1) Distant metastasis was diagnosed by CT /mr/ PET-CT. 2) Received previous anti-tumor treatment, including chemotherapy, radiotherapy or immunotherapy. 3) Other malignant tumors (except basal cell or squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ or breast cancer) in the past 5 years. 4) Uncontrollable pleural effusion, pericardial effusion or ascites. 5) Severe cardiovascular diseases, such as symptomatic coronary heart disease, congestive heart failure = grade II, uncontrolled arrhythmia and myocardial infarction, occurred within 12 months before enrollment. 6) Complicated with serious uncontrolled concurrent infection or other serious uncontrolled concomitant diseases, moderate or severe renal injury. 7) Allergic reaction to the drugs used in this study. 8) Steroid or other systemic immunosuppressive therapy was used 14 days before recruitment. 9) Pregnant or lactating women or women of childbearing age were positive in the baseline pregnancy test. The researchers evaluated the patients with poor compliance and could not guarantee the treatment and follow-up of patients according to the study protocol.

Design outcomes

Primary

MeasureTime frame
AEs;R0 resection rate;

Secondary

MeasureTime frame
ORR;DOR;PFS;RFS;OS;

Countries

China

Contacts

Public ContactHuang Xiaobing

The Second Affiliated Hospital of the Army Medical University

1038915320@qq.com13372618116

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 29, 2026