Sintilimab combined with chemotherapy and radiotherapy for inoperable pancreatic cancer

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

This study is testing if combining the immunotherapy drug Sintilimab with chemotherapy and radiotherapy can help people with inoperable pancreatic cancer live longer and feel better.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 25 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Shandong Cancer Hospital and Institute (other)
• Drugs / interventions: Sintilimab, chemotherapy, immunotherapy, Radiation
• Locations: 1 site (Jinan, Shandong)
• Trial ID: NCT06050317 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of Sintilimab, an immunotherapy drug, in combination with chemotherapy and radiotherapy for patients with inoperable pancreatic cancer. The study aims to improve survival rates in this patient population, which currently faces a grim prognosis due to the aggressive nature of the disease. Participants will receive a multidisciplinary treatment approach, focusing on enhancing anti-tumor responses. The trial includes patients who have not previously undergone systemic anti-tumor therapy and have confirmed unresectable locally advanced pancreatic cancer.

Who should consider this trial

Good fit: Ideal candidates are patients with unresectable locally advanced pancreatic cancer who have not received prior systemic anti-tumor therapy.

Not a fit: Patients with other malignant diseases or those who have previously received certain immunotherapy drugs may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly extend survival for patients with inoperable pancreatic cancer.

How similar studies have performed: While there have been trials exploring chemotherapy and radiotherapy for pancreatic cancer, the combination with Sintilimab represents a novel approach that has not been extensively tested.

Eligibility criteria

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.

Where this trial is running

Jinan, Shandong

• Department of Radiation Oncology, Shandong Cancer Hospital and Institute — Jinan, Shandong, China (RECRUITING)

Study contacts

• Principal investigator: Jinbo Yue, dorctor — Shandong Cancer Hospital and Institute
• Study coordinator: Jinbo Yue, dorctor

Conditions: Pancreas Cancer, Immunothrapy, Chemotherapy, Radiothrapy, Pancreatic cancer