Trial Title:
Neoadjuvant/Adjuvant Sintilimab, Nab-paclitaxel, and Gemcitabine for Resectable/Borderline Resectable Pancreatic Cancer
NCT ID:
NCT05562297
Condition:
Pancreatic Cancer, Stage IB
Pancreatic Cancer, Stage IIA
Pancreatic Cancer, Stage IIB
Pancreatic Cancer Stage III
Conditions: Official terms:
Pancreatic Neoplasms
Paclitaxel
Gemcitabine
Conditions: Keywords:
Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma
Sintilimab
Nab-paclitaxel
Gemcitabine
Neoadjuvant Therapy
Adjuvant Therapy
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
sintilimab
Description:
Patients firstly receive sintilimab 200 mg (iv, 30 minutes) on day 1 for 3 weeks,
followed by one week without treatment. Treatment repeats every 4 weeks for up to 3
circles in the absence of disease recurrence or unacceptable toxicity.
Arm group label:
sintilimab + nab-paclitaxel + gemcitabine
Other name:
Tyvyt
Intervention type:
Drug
Intervention name:
nab-paclitaxel
Description:
Patients firstly receive nab-paclitaxel 125 mg/m^2 (iv, 30 minutes) on days 1, and 8 for
3 weeks, followed by one week without treatment. Treatment repeats every 4 weeks for up
to 3 circles in the absence of disease recurrence or unacceptable toxicity.
Arm group label:
sintilimab + nab-paclitaxel + gemcitabine
Other name:
Abraxane
Intervention type:
Drug
Intervention name:
gemcitabine
Description:
Patients secondly receive gemcitabine 1000 mg/m^2 (iv, 30 minutes) on days 1, and 8 for 3
weeks, followed by one week without treatment. Treatment repeats every 4 weeks for up to
3 circles in the absence of disease recurrence or unacceptable toxicity.
Arm group label:
sintilimab + nab-paclitaxel + gemcitabine
Other name:
GEMZAR
Summary:
The purpose of this research is to investigate the activity and safety of the combination
of gemcitabine plus nab-paclitaxel and sintilimab as neoadjuvant therapy in treating
patients with resectable and borderline resectable pancreatic cancer.
The drugs involved in this study are:
- Sintilimab
- Nab-paclitaxel
- Gemcitabine
Detailed description:
Pancreatic cancer is a highly fatal disease with a 5-year survival rate of less than 5%,
and it is becoming an increasingly common cause of cancer mortality. Neoadjuvant therapy,
such as gemcitabine plus nab-paclitaxel, can effectively avoid the proliferation of
residual tumors and reduce the risk of lymph node metastasis, implantation metastasis
during surgery, and early relapse after operation. Most importantly, it can change the
immune status by turning the "immune cold" pancreatic cancer into an "immune hot"
condition, which will enable the application of immune checkpoint inhibitors. Sintilimab
is an immune checkpoint inhibitor against programmed cell death protein 1, which is
applicable for treatment of a range of cancers including non-small cell lung cancer,
melanoma, esophageal cancer, and liver cancer. It could block the interaction between
PD-1 and its ligands and help the anti-tumor effect of T cells to recover. The present
study is intended to investigate the activity and safety of the combination of
gemcitabine plus nab-paclitaxel and sintilimab as neoadjuvant therapy in treating
patients with resectable and borderline resectable pancreatic cancer.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Signed informed content obtained prior to treatment
- Age ≥ 18 years and ≤ 75 years
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Patients must have imaging evaluations to confirm that their pancreatic
adenocarcinoma is resectable and borderline resectable. Patients must have
histologically confirmed pancreatic adenocarcinoma, too.
- Therapy-naïve for their pancreatic cancer. Patients should receive no anti-tumor
treatment, including systemic chemotherapy, interventional chemotherapy, high-energy
focused ultrasound, radiotherapy, immunotherapy, molecular targeted therapy, and
anti-tumor Chinese medicine therapy.
- No serious dysfunction in blood system, heart, lung function, or autoimmune system
(refer to the respective diagnostic criteria)
- White blood cell (WBC) ≥ 3 × 109/L; Absolute neutrophil count (ANC) ≥ 1.5 × 109/L;
Platelets (PLT) ≥ 100 × 109/L; Hemoglobin (Hgb) ≥ 90 g/L
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]/
alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase [SGPT]) ≤ 2.5 ×
institutional upper limit of normal (ULN); Total bilirubin (TBIL) ≤ ULN; Creatinine
(CRE) ≤ 1.5 × ULN
- Prothrombin time (PT) and international normalized ratio (INR) ≤ 1.5 × ULN
- Able to comply with research visit plans and other protocol requirements.
Exclusion Criteria:
- The diameter of the resectable tumor is ≤ 2 cm in imaging evaluation
- Associated with other malignant tumors
- Patients receiving anti-tumor treatment before neoadjuvant therapy, including
systemic chemotherapy, interventional chemotherapy, high-energy focused ultrasound,
radiotherapy, immunotherapy, molecular targeted therapy, and anti-tumor Chinese
medicine therapy
- Use of any other investigational agents
- Patients with uncontrolled intercurrent illness including, but not limited to
ongoing or active infection, internal hemorrhage, pancreatic leakage, bile leakage,
symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia,
or psychiatric illness/social situations that would limit compliance with study
requirements
- Pregnant or nursing women
- History of allergic reactions attributed to compounds of similar chemical or
biological composition to nab-paclitaxel, gemcitabine, or sintilimab
- Patients who are using and need to use warfarin for a long period
- Patients who are unwilling or unable to comply with study procedures
- Patients who are expected to be out of the observation period for 14 days or more
during the treatment
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Zhongshan Hospital
Address:
City:
Shanghai
Zip:
200000
Country:
China
Contact:
Last name:
Wen-Quan Wang, MD, PhD
Phone:
+86 21 31587861
Email:
wang.wenquan@zs-hospital.sh.cn
Investigator:
Last name:
Liang Liu, MD, PhD
Email:
Principal Investigator
Investigator:
Last name:
Wen-hui Lou, MD, PhD
Email:
Principal Investigator
Start date:
July 1, 2023
Completion date:
October 1, 2026
Lead sponsor:
Agency:
Shanghai Zhongshan Hospital
Agency class:
Other
Collaborator:
Agency:
Fudan University
Agency class:
Other
Source:
Shanghai Zhongshan Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05562297
