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

NCT05562297 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: ZSPAC-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

Pancreatic Cancer; Pancreatic Ductal Adenocarcinoma; Sintilimab; Nab-paclitaxel; Gemcitabine; Neoadjuvant Therapy; Adjuvant Therapy

Outcome Measures

Primary Outcomes (1)

• 2-year overall survival after the application of sintilimab and gemcitabine plus nab-paclitaxel

  To evaluate the overall survival of patients with resectable and borderline resectable pancreatic cancer treated with the combination of sintilimab and gemcitabine plus nab-paclitaxel. Outpatient visit, phone interview

  From date of enrollment to the date of death for any cause, assessed 2 months during therapy and 3 months thereafter up to 24 months

Secondary Outcomes (14)

• Overall survival after the application of sintilimab and gemcitabine plus nab-paclitaxel

  From date of enrollment until the date of death from any cause, assessed one month during therapy and 3 months thereafter up to 24 months

• Event-free survival after the application of sintilimab and gemcitabine plus nab-paclitaxel

  From date of enrollment until the date of death from any cause, assessed one month during therapy and 3 months thereafter up to 24 months

• Objective response rate and disease control rate after finishing the course of the treatment of sintilimab and gemcitabine plus nab-paclitaxel

  One month during therapy and 3 months thereafter up to 24 months

• Recurrence-free survival after finishing the course of the treatment of sintilimab and gemcitabine plus nab-paclitaxel and curative resection

  One month during therapy and 3 months thereafter up to 24 months

• Resection rate and R0 resection rate after finishing the course of the treatment of sintilimab and gemcitabine plus nab-paclitaxel and curative resection

  One month during therapy and 3 months thereafter up to 24 months

Study Arms (1)

sintilimab + nab-paclitaxel + gemcitabine

EXPERIMENTAL

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;

Drug: sintilimab; Drug: nab-paclitaxel; Drug: gemcitabine

Interventions

sintilimab 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.

Also known as: Tyvyt

sintilimab + nab-paclitaxel + gemcitabine

nab-paclitaxel 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.

Also known as: Abraxane

sintilimab + nab-paclitaxel + gemcitabine

gemcitabine 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.

Also known as: GEMZAR

sintilimab + nab-paclitaxel + gemcitabine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead
• Fudan University: collaborator

Study Sites (1)

Zhongshan Hospital

Shanghai, Shanghai Municipality, 200000, China

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

sintilimab; 130-nm albumin-bound paclitaxel; Albumin-Bound Paclitaxel; Gemcitabine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Liang Liu, MD, PhD

  Shanghai Zhongshan Hospital

  PRINCIPAL INVESTIGATOR

• Wen-hui Lou, MD, PhD

  Shanghai Zhongshan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wen-Quan Wang, MD, PhD

CONTACT

+86 21 31587861; wang.wenquan@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2022
• First Posted: September 30, 2022
• Study Start: March 20, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2028
• Last Updated: January 22, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)