Sintilimab Combined With Chemotherapy and Radiotherapy in Patients With Inoperable Pancreatic Cancer

September 21, 2023 updated by: Jinbo Yue, Shandong Cancer Hospital and Institute

Sintilimab Plus Chemotherapy and Radiotherapy for Patients With Inoperable Pancreatic Cancer: a Single-arm, Exploratory, Phase II Trial

Hypothesis: Survival benefits could be found in Sintilimab plus chemotherapy and radiotherapy in patients with inoperable pancreatic cancer.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Background and aim:

Pancreatic cancer, characterized by its aggressive nature and dismal prognosis, exhibits one of the lowest 5-year survival rates among all solid tumors, standing at a mere 7%. Alarming projections suggest that by the year 2030, it will ascend to become the second leading cause of cancer-related deaths. This dire scenario is further compounded by the stealthy onset of the disease, with an overwhelming 80-85% of patients already presenting with unresectable pancreatic cancer at the time of initial diagnosis.

Clinical trials have endeavored to extend the survival of this challenging patient subset through the administration of chemotherapy or chemoradiotherapy. While these interventions have shown some promise, the overall response rate remains disappointingly low, and patients continue to grapple with a bleak prognosis, often surviving less than a year. This unmet medical need underscores the critical demand for more effective therapeutic modalities in the management of pancreatic cancer, as the lack of viable treatment options remains a primary driver of its high mortality rate.

The traditional therapeutic landscape for unresectable pancreatic cancer primarily relies on single-agent chemotherapy. However, there is a growing realization within the medical community that a paradigm shift toward a multidisciplinary approach is imperative. The crux of achieving long-term survival for pancreatic cancer patients lies in the attainment of a durable anti-tumor response.

Targeted PD-(L)1 immunotherapy, renowned for its ability to induce enduring anti-tumor responses by harnessing the body's own immune system, has yielded remarkable results in various malignancies. Paradoxically, the success of single-agent immunotherapy in pancreatic cancer has been elusive, a phenomenon possibly attributed to the tumor's intrinsic genetic mutations and the hostile, immunosuppressive microenvironment that envelops pancreatic tumors.

Radiation therapy has emerged as a potential ally in this battle against pancreatic cancer. It has been demonstrated to augment the release of tumor-associated antigens, thereby priming the immune system for a more robust response. In response to the resistance encountered with PD-(L)1 monotherapy, researchers have embarked on a journey of preclinical and clinical investigations aimed at validating the combinatorial approach of PD-(L)1 inhibitors alongside chemotherapy and radiation therapy.

The fundamental premise underlying the synergy of radiation and immunotherapy is rooted in the non-invasive initiation of the immune system against tumor cells. Radiation serves as a catalyst, promoting antigen presentation and co-stimulation, culminating in the generation of an immune response targeted at epitopes that had remained concealed within distant metastases. Immune checkpoint inhibitors play a pivotal role in reversing the immunosuppressive effects of the tumor microenvironment, thereby fostering a milieu conducive to anti-tumor immunity.

While the efficacy of this integrative approach remains uncharted territory, current recommendations advocate for a first-line treatment strategy consisting of chemotherapy with optional radiation therapy. Targeted therapy and immunotherapy are not currently included in the initial treatment regimen. Consequently, the primary aim of our study is to explore and elucidate the outcomes of combining Sintilimab with radiation therapy and chemotherapy in the treatment of unresectable pancreatic cancer, offering a glimmer of hope in a landscape fraught with challenges and adversity.

Study Type

Interventional

Enrollment (Estimated)

25

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 0531
        • Recruiting
        • Department of Radiation Oncology, Shandong Cancer Hospital and Institute
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • ECOG PS 0-1
  • Pathological tissue-confirmed unresectable locally advanced pancreatic cancer
  • Pancreatic cancer patients who have not received systemic anti-tumor therapy
  • Primary pancreatic cancer or at least one measurable lesion specified by RECIST1.1 standards
  • A life expectancy of > 3 months
  • Blood routine examination: Absolute neutrophil count (ANC) ≥ 1.0 ×109 cells/L, platelets ≥ 75×109 cells/L, hemoglobin ≥ 9.0 g/dl
  • AST<2.5 × ULN(Upper Limit of Normal), ALT<2.5 × ULN,creatinine ≤1.5xULN, total bilirubin < ≤1.5 X ULN.

Exclusion Criteria:

  • Diagnosed with other malignant diseases other than pancreatic cancer within three years before enrollment
  • Patients who are currently participating in interventional clinical research treatment or have received other research drugs or used research devices within four weeks before enrollment
  • Patients who have previously received anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs or another drug that stimulates or synergistically inhibits T-cell receptors
  • Patients who have received systemic treatment with Chinese patent medicines with anti-tumor indications or drugs with immunomodulatory effects within two weeks before enrollment
  • Abnormal results of blood routine examinations and liver and kidney and coagulation tests
  • Abnormal function of major organs (14 days before enrollment)
  • Women who are pregnant
  • Inability of the research subject or authorized legal representative to understand and the willingness to sign a written informed consent document.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sintilimab Plus Chemotherapy and Radiotherapy
Sintilimab Plus mFFN and Radiation
Drug: Sintilimab Plus mFFN and Radiation
Sintilimab Plus mFFN and Radiation
Other Names:
  • Arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS
Time Frame: 2 year
Time from first dose of study drug to first radiographic disease progression or death, whichever occurs first
2 year
AE
Time Frame: 2 year
Advent event rate
2 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overal response rate
Time Frame: 2 year
Proportion of subjects with complete response (CR) and partial response (PR) to total subjects; including assessment of irradiated lesions and non-irradiated lesions
2 year
Overall survival
Time Frame: 2 year
The time from the start of treatment to death
2 year
Disease control rate
Time Frame: 2 year
Proportion of total subjects defined as complete response (CR), partial response (PR), and stable disease (SD)
2 year
Duration of response
Time Frame: 2 year
The time from when the tumor is first evaluated as CR or PR to when the tumor is first evaluated as PD (Progressive Disease) or death from any cause
2 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shandong Cancer Hospital and Institute

Investigators

  • Principal Investigator: Jinbo Yue, dorctor, Shandong Cancer Hospital and Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 18, 2023

Primary Completion (Estimated)

August 18, 2025

Study Completion (Estimated)

August 18, 2026

Study Registration Dates

First Submitted

September 17, 2023

First Submitted That Met QC Criteria

September 21, 2023

First Posted (Actual)

September 22, 2023

Study Record Updates

Last Update Posted (Actual)

September 22, 2023

Last Update Submitted That Met QC Criteria

September 21, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SDZLEC2023-227-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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