Neoadjuvant/Adjuvant Sintilimab, Nab-paclitaxel, and Gemcitabine for Resectable/Borderline Resectable Pancreatic Cancer

NCT ID: NCT05562297

Last Updated: 2025-01-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-20
• Study Completion Date: 2028-10-01

Brief 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.

Conditions

Pancreatic Cancer, Stage IB; Pancreatic Cancer, Stage IIA; Pancreatic Cancer, Stage IIB; Pancreatic Cancer Stage III

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

sintilimab + nab-paclitaxel + gemcitabine

Experimental: sintilimab + nab-paclitaxel + gemcitabine nab-paclitaxel at 125 mg/m\^2 on days 1, and 8; gemcitabine at 1000 mg/m\^2 on days 1, and 8; sintilimab at 200mg on day 1;

Group Type: EXPERIMENTAL

sintilimab

Intervention Type: DRUG

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.

nab-paclitaxel

Intervention Type: DRUG

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.

gemcitabine

Intervention Type: DRUG

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.

Interventions

sintilimab

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.

Intervention Type: DRUG

nab-paclitaxel

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.

Intervention Type: DRUG

gemcitabine

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.

Intervention Type: DRUG

Other Intervention Names

Tyvyt; Abraxane; GEMZAR

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: collaborator

Shanghai Zhongshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Liang Liu, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Zhongshan Hospital

Wen-hui Lou, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Zhongshan Hospital

Locations

Zhongshan Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Central Contacts

Wen-Quan Wang, MD, PhD

Role: CONTACT

wang.wenquan@zs-hospital.sh.cn

+86 21 31587861

Facility Contacts

Wen-Quan Wang, MD, PhD

Role: primary

wang.wenquan@zs-hospital.sh.cn

+86 21 31587861

Other Identifiers

ZSPAC-01

Identifier Type: -

Identifier Source: org_study_id