Efficacy and Safety of SHR-1020 Combined With Albumin-bound Paclitaxel in the Second-line Treatment of Pancreatic Cancer

Pancreatic Cancer Clinical Trial

Official title:

A Prospective, Single-center Clinical Study to Explore the Efficacy and Safety of SHR-1020 Combined With Albumin-bound Paclitaxel in the Second-line Treatment of Pancreatic Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04814485
• Other study ID #: PANC-2nd-IIT-FMTN-naP
• Status: Recruiting
• Phase: Phase 2
• Start date: April 22, 2021
• Est. completion date: July 2023

Study information

• Verified date: December 2020
• Source: Tianjin Medical University Cancer Institute and Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is being conducted to explore the efficacy and safety of SHR-1020 combined with albumin-bound paclitaxel in the second-line treatment of advanced pancreatic cancer.

Description:

This trial is a prospective, single-center, single-arm clinical research. Advanced pancreatic cancer is an aggressive disease with extremely low 5-year survival rate. For advanced pancreatic cancer patients who failed with first-line treatment, subsequent treatment options are limited. SHR-1020 combined with albumin-bound paclitaxel could through multiple mechanisms such as block tumor mitosis, inhibit tumor angiogenesis, inhibit interstitial fibrosis to achieve anti-tumor effect.

The safety and efficacy of this study will be assessed through ORR, DCR,PFS, OS , and adverse effects as graded by CTCAE 5.0.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 39
• Est. completion date: July 2023
• Est. primary completion date: July 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patients who were diagnosed as metastatic or locally advanced unresectable pancreatic ductal adenocarcinoma by histopathology or cytology, at least one measurable lesion conforming to RECIST 1.1 criteria.

• Disease progresses or intolerance for first-line standard treatment, including patients who relapsed or metastasized within 6 months of neoadjuvant or adjuvant therapy

• ECOG score 0-2

• Adequate organ and bone marrow function

• The expected survival time is = 12 weeks

• Had normal swallowing function, without dysfunction of gastrointestinal absorption

• Willing to consent and signed the informed consent, and able comply with the planned visit, research treatment, laboratory examination and other test procedures

Exclusion Criteria:

• The patient has previously received anti-angiogenic drugs or albumin-bound paclitaxel;

• The first study drug treatment was less than 2 weeks or 5 half-lives (in terms of longer) from the last chemotherapy or 5 half-lives from the last targeted therapy

• Known to be allergic to the active ingredients or excipients in this study.

• Had other active malignant tumors within 5 years before entering the study.

• Subject with cerebral metastasis

• Have a clear history of serious and uncontrolled other disease or mental disorders;

• Other chemotherapy, targeted therapy, hormonotherapy, immunotherapy, radiotherapy or traditional Chinese medicine should be used for anti-tumor therapy

• Other situations that the researcher considers inappropriate to participate in the research.

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• SHR-1020+albumin-bound paclitaxel
SHR-1020 combined with albumin-bound paclitaxel for advanced pancreatic cancer

Locations

Country	Name	City	State
China	Tianjin Medical University Cancer Institute and Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Medical University Cancer Institute and Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ORR (Objective Response Rate)	Containing the incidence of complete response (CR) and partial response (PR). Evaluated according to RECIST 1.1 criteria,subjects received their first tumor imaging evaluation at 8 weeks after the treatment start, followed by imaging evaluation every 2 cycles.	From date of first dose until the date of first documented progression or date of death from any cause, whichever came first,assessed up to 12 months]
Secondary	DCR (Disease Control Rate)	Containing the incidence of complete response (CR), partial response (PR) and stable disease (SD).Evaluated according to RECIST 1.1 criteria,subjects received their first tumor imaging evaluation at 8 weeks after the treatment start, followed by imaging evaluation every 2 cycles.	From date of first dose until the date of first documented progression or date of death from any cause, whichever came first,assessed up to 12 months]
Secondary	PFS (Progression-Free-Survival)	From date of treatment start until the date of progression or the date of death due to any cause.Evaluated according to RECIST 1.1 criteria,subjects received their first tumor imaging evaluation at 8 weeks after the treatment start, followed by imaging evaluation every 2 cycles.	From date of treatment start until the date of progression or the date of death due to any caus, assessed up to 12 months
Secondary	6mPFS	6-month- Progression-Free-Survival rate. Evaluated according to RECIST 1.1 criteria,subjects received their first tumor imaging evaluation at 8 weeks after the treatment start, followed by imaging evaluation every 2 cycles.	Up to 6 months
Secondary	OS (overall survival)	From date of treatment start to any cause death or last follow-up.	From date of treatment start until the date of death from any cause or censored at the last day that the patient is documented to be alive, whichever came first, assessed up to 12 months
Secondary	Adverse events (per CTCAE v5.0 criteria)	To evaluate the adverse events of patients with advanced pancreatic cancer after treated with SHR-1020 plus albumin-bound paclitaxel	Up to 12months