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Clinical trial of the efficacy and safety of Camrelizumab combined with chemotherapy in the treatment of advanced Pancreatic Adenocarcinoma

Clinical trial of the efficacy and safety of Camrelizumab combined with chemotherapy in the treatment of advanced Pancreatic Adenocarcinoma

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100046966
Enrollment
Unknown
Registered
2021-06-05
Start date
2021-06-08
Completion date
Unknown
Last updated
2022-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

???

Interventions

Sponsors

Shandong Provincial Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 70 years; 2. Patients with advanced pancreatic adenocarcinoma and locally advanced pancreatic adenocarcinoma diagnosed by histology or cytology; 3. Patients who have not received systemic chemotherapy in the past, or who have progressed to first-line treatment; 4. There is at least one measurable lesion (according to the RECIST 1.1 standard, the long diameter of the CT scan of tumor 1. Age: 18-70 years old; 2. Patients with advanced pancreatic cancer and locally advanced pancreatic cancer diagnosed by histology or cytology; 3. Patients who have not received systemic chemotherapy in the past, or who have progressed to first-line treatment; 4. There is at least one measurable lesion (according to the RECIST 1.1 standard, the long diameter of the CT scan of tumor lesions is >= 10mm, and the short diameter of CT scan of lymph node lesions is >= 15mm); 5. ECOG score: 0-1 points; 6. Estimated survival period >= 3 months; 7. The main organs are functioning normally, that is, they meet the following standards: (1) Routine blood examination standards must meet (no blood transfusion and blood products within 14 days): 1) ANC>=1.5x10^9/L; 2) PLT>=80x10^9/L; (2) The biochemical inspection shall meet the following standards: 1) TBIL 45 ml/min (Cockcroft-Gault formula); 8. Subjects voluntarily joined the study, signed an informed consent form, had good compliance, and cooperated with follow-up.

Exclusion criteria

Exclusion criteria: 1. The subject has any active autoimmune disease or a history of autoimmune disease; 2. According to NYHA standards, grade III to IV cardiac insufficiency, or cardiac color Doppler ultrasound examination reveals that the left ventricular ejection fraction (LVEF) is less than 50%; 3. Abnormal blood coagulation function (INR>1.5 APTT>1.5 ULN), with bleeding tendency; 4. Long-term unhealed wounds or fractures; major surgical operations or severe traumatic injuries, fractures or ulcers occurred within 4 weeks; 5. Subjects with congenital or acquired immune function defects (such as HIV infection), or active hepatitis (hepatitis B reference: HBV DNA test value exceeds the upper limit of normal value; hepatitis C reference: HCV virus titer or RNA test value exceeds the upper limit of normal value ); 6. Known hereditary or acquired bleeding and thrombotic tendency (such as hemophilia patients, coagulation dysfunction, thrombocytopenia, hypersplenism, etc.) or hyperactivity in the past 6 months (to the first SHR-1210 medication), Venous thrombosis events; 7. Subjects have active infections or have unexplained fever> 38.5 degrees during the screening period and before the first administration; 8. Patients with central nervous system metastasis; 9. Those who have received live vaccine or live attenuated vaccine within 30 days before receiving research treatment for the first time; 10. The subject has suffered from other malignant tumors in the past or at the same time; 11. Pregnant or lactating women; 12. Those who have a history of psychotropic drug abuse and cannot be quit or those who have mental disorders; 13. According to the judgment of the investigator, patients with concomitant diseases that seriously endanger the safety of the patient or affect the completion of the study; 14. The researcher believes that it is not suitable for inclusion.

Design outcomes

Primary

MeasureTime frame
Objective response rate;

Secondary

MeasureTime frame
Progression-free survival;Overall survival;Remission maintenance time;Disease control rate;

Countries

China

Contacts

Public ContactWang Yu

Shandong Provincial Hospital

sangyingchun1227@163.com+86 15634100013

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026