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

NCT06050317 | Recruiting Phase 2

• 1 other identifier: SDZLEC2023-227-02
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pancreas Cancer

Keywords

Immunothrapy; Chemotherapy; Radiothrapy; Pancreatic cancer

Outcome Measures

Primary Outcomes (2)

• PFS

  Time from first dose of study drug to first radiographic disease progression or death, whichever occurs first

  2 year

• AE

  Advent event rate

  2 year

Secondary Outcomes (4)

• Overal response rate

  2 year

• Overall survival

  2 year

• Disease control rate

  2 year

• Duration of response

  2 year

Study Arms (1)

Sintilimab Plus Chemotherapy and Radiotherapy

EXPERIMENTAL

Sintilimab Plus mFFN or NALIRIFOX and Radiation

Drug: Sintilimab Plus mFFN or NALIRIFOX and Radiation

Interventions

Sintilimab Plus mFFN or NALIRIFOX and Radiation DRUG

Sintilimab Plus mFFN or NALIRIFOX and Radiation

Also known as: Arm

Sintilimab Plus Chemotherapy and Radiotherapy

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shandong Cancer Hospital and Institute: lead

Study Sites (1)

Department of Radiation Oncology, Shandong Cancer Hospital and Institute

Jinan, Shandong, 0531, China

RECRUITING

Related Publications (23)

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MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

sintilimab; Radiation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Physical Phenomena

Study Officials

• Jinbo Yue, dorctor

  Shandong Cancer Hospital and Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jinbo Yue, dorctor

CONTACT

0531-67626442; yuejinbo@hotmail.com

Lei Xu, dorctor

CONTACT

0531-67626442; Len.Xu@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Jinbo Yue

Model Details: Sintilimab Plus Chemotherapy and Radiotherapy

Study Record Dates

• First Submitted: September 17, 2023
• First Posted: September 22, 2023
• Study Start: August 18, 2023
• Primary Completion: August 18, 2025
• Study Completion (Estimated): August 18, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)