Cadonilimab Combined With S-1 Or Capecitabine As Second-line Treatment For Advanced Pancreatic Cancer

Study Overview

Cadonilimab Combined With S-1 or Capecitabine as Second-line Treatment for Advanced Pancreatic Cancer

This is a single arm, single cencer, phase II clinical trial. This study aims to evaluate the efficacy and safety of Cadonilimab combined with S-1 or capecitabine as a second-line treatment for advanced pancreatic cancer.

N/A

Pancreatic Neoplasms

DRUG: Cadonilimab+S-1or Capecitabine

20240515024702669

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 Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2024-07-30	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-05-13
First Submitted that Met QC Criteria 2024-07-30	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-05-14
First Posted (ACTUAL) 2024-08-01	Results First Posted N/A	Last Verified 2025-05

Study Plan

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

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Cadonilimab+S-1or Capecitabine	DRUG: Cadonilimab+S-1or Capecitabine Eligible patients will receive Cadonilimab (6mg/k, iv, D1,Q3W)combined with S-1 (40-60mg po BID Q3W D1-14）or Capecitabine (1250mg/m2, po BID Q3W D1-14）until disease progression or unacceptable toxicity. Patients who had used S-1 in the first line should c

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Cadonilimab+S-1or Capecitabine

DRUG: Cadonilimab+S-1or Capecitabine

Eligible patients will receive Cadonilimab (6mg/k, iv, D1,Q3W)combined with S-1 (40-60mg po BID Q3W D1-14）or Capecitabine (1250mg/m2, po BID Q3W D1-14）until disease progression or unacceptable toxicity. Patients who had used S-1 in the first line should c

Primary Outcome Measures	Measure Description	Time Frame
Objective response rate (ORR)	Defined as the proportion of patients with a complete response or partial response to treatment according to RECIST1.1	Up to 2 years

Secondary Outcome Measures	Measure Description	Time Frame
Overall survival (OS)	Defined as the length of time from the first dose to death from any cause.	Up to 2 years
Progression-free survival (PFS)	Defined as the length of time from the first dose to progression disease or death from any cause.	Up to 2 years
Disease control rate (DCR)	Defined as the proportion of patients with a complete response, partial response or stable disease to treatment according to RECIST1.1	Up to 2 years
Duration of response (DoR)	Defined as the length of time from first tumor response (CR or PR) to disease progression (PD) or death.	Up to 2 years

Contacts and Locations

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

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Signed written informed consent
Age 18-80, female or male
Histopathologically confirmed pancreatic ductal adenocarcinoma
Patients with locally advanced pancreatic cancer who have previously received standard first-line anti-tumor treatment (radiotherapy, chemotherapy, targeted or immunotherapy, etc.)
Locally advanced pancreatic cancer is defined as follows: a. The tumor has no distant metastasis; b. Pancreatic head/uncinate process: The tumor contacts the superior mesenteric artery >180˚; c. Pancreatic body and tail: The tumor contacts the superior mesenteric artery or celiac artery >180˚; The tumor contacts the celiac artery and infiltrates the abdominal aorta; d. The tumor invades the jejunal branch of the superior mesenteric artery. Portal vein-superior mesenteric vein cannot be safely reconstructed due to tumor invasion, vein occlusion, or involvement of a large range of jejunal branches of the superior mesenteric vein.
At least one measurable lesion (RECIST1.1)
ECOG PS 0-1
Expected survival time>3 months
Adequate organ function

Malignant diseases other than pancreatic cancer diagnosed within 5 years before the first dose (excluding radically resected basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or radically resected carcinoma in situ)
Currently participating in interventional clinical research treatment, or having received other research drugs or used research devices within 4 weeks before the first dose
Active autoimmune disease
Allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation
Allergic to the active ingredients or excipients of this study drug, cadonilimab, S-1 or capecitabine
Have not fully recovered from any toxicity and/or complications caused by the intervention before starting treatment
History of HIV
Active HBV or HCV
Pregnant or breastfeeding women
Any severe or uncontrolled systemic disease
Active pulmonary tuberculosis
People with mental disorders who are unable to cooperate with treatment
Uncontrolled infection
The investigators assess that the subjects are unable to complete the entire trial process or are otherwise unsuitable for participating in this trial

Collaborators and Investigators

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

Publications

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

General Publications

No publications available

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Clinical Trial Record