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Gemcitabine plus nab-paclitaxel, paricalcitol and PD-1 antibody for locally advanced pancreatic cancer: a phase II, single center, single arm study

Gemcitabine plus nab-paclitaxel, paricalcitol and PD-1 antibody for locally advanced pancreatic cancer: a phase II, single center, single arm study

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000034398
Enrollment
Unknown
Registered
2020-07-04
Start date
2020-08-01
Completion date
Unknown
Last updated
2020-07-06

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

Conditions

Pancreatic cancer

Interventions

experimental group:gemcitabine plus nab-paclitaxel, paricalcitol and PD-1 antibody

Sponsors

Sun Yat-Sen Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Volunteer to participate and sign written informed consent; 2. Age: 18-72 years old; 3. Pancreatic ductal carcinoma was diagnosed by histology or cytology; 4. MDT team of cancer prevention and treatment center of Sun Yat-Sen University discussed patients with locally advanced pancreatic cancer . 5. The expected survival time was more than 3 months; 6. Be able to take medicine orally; 7. Karnofsky physical fitness score (KPS) >= 70; 8. Proper organ function (within 7 days), as follows: a) AST and ALT = 90g/L, NE>=1.5*10^9/L, PLT >= 90*10^9/L; c) Creatinine clearance rate >= 60 ml / min (based on serum creatinine). 9. Willing and able to follow test visits, test plans, laboratory inspections and other test procedures.

Exclusion criteria

Exclusion criteria: 1. Have received the following treatment in the past: a) Any previous chemotherapy before; b) Any previous radiotherapy or immunotherapy; c) Any investigational drug has been or is being received in the past 30 days; d) Previous surgery within 3 weeks (including ablation, exploration). 2. Previous or present combined with other malignant tumors (except for skin basal cell carcinoma and cervical carcinoma in situ); 3. Other serious diseases or physical conditions, including: a) Patients with severe heart disease history include: congestive heart failure, high risk uncontrollable arrhythmia and hypertension, angina pectoris requiring drug treatment, and history of severe myocardial infarction; b) Active infection or active infectious disease; c) Known gastrointestinal disorders at the time of enrollment, including dyspepsia, diarrhea, etc.; d) Habitual nausea, vomiting or diarrhea; e) Poorly controlled diabetes. 4. With serious complications such as active gastrointestinal bleeding, perforation, jaundice, intestinal obstruction, etc.; 5. Mental disorders, which may affect the recognition of informed consent and the implementation of the experimental scheme; 6. Other severe acute or chronic physical discomfort and abnormal laboratory examination may increase the expected risk of the trial, affect the progress of treatment, or interfere with the results of the study. The investigator shall judge whether the subject is eligible for the trial; 7. Pregnant and lactating women, or subjects who are fertile but refuse to use appropriate contraceptive measures.

Design outcomes

Primary

MeasureTime frame
ORR;

Secondary

MeasureTime frame
OS;AEs;SR;

Countries

China

Contacts

Public ContactLi shengping

Sun Yat-Sen Cancer Center

lishp@sysucc.org.cn+86 13922755669

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026