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

Phase 2

• Conditions: Pancreatic Cancer
• Interventions: Drug: SHR-1020+albumin-bound paclitaxel

• Registration Number: NCT04814485
• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital

Brief 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.

Detailed 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.

Study Timeline

• Status Verified: 2020-12
• Study First Submitted: 2021-03-17
• Study First Submitted QC: 2021-03-22
• Study First Posted: 2021-03-24
• Study Start: 2021-04-22
• Last Update Submitted: 2021-05-21
• Last Update Posted: 2021-05-25
• Primary Completion: 2023-07
• Study Completion: 2023-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 39

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SHR-1020 combined with albumin-bound paclitaxel	SHR-1020+albumin-bound paclitaxel	SHR-1020 combined with albumin-bound paclitaxel

Primary Outcome Measures

Name	Time	Method
ORR (Objective Response Rate)	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]	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.

Secondary Outcome Measures

Name	Time	Method
Adverse events (per CTCAE v5.0 criteria)	Up to 12months	To evaluate the adverse events of patients with advanced pancreatic cancer after treated with SHR-1020 plus albumin-bound paclitaxel
DCR (Disease Control Rate)	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]	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.
PFS (Progression-Free-Survival)	From date of treatment start until the date of progression or the date of death due to any caus, assessed up to 12 months	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.
6mPFS	Up to 6 months	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.
OS (overall survival)	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	From date of treatment start to any cause death or last follow-up.

Trial Locations

Locations (1)

Tianjin Medical University Cancer Institute and Hospital; 🇨🇳 Tianjin, Tianjin, China