SHR6390 Plus Nab-paclitaxel and Gemcitabine in Advanced/Metastatic Pancreatic Cancer

Pancreatic Cancer Clinical Trial

Official title:

A Phase II Study of SHR6390 Plus Nab-paclitaxel and Gemcitabine in Unresectable Advanced/Metastatic Pancreatic Ductal Adenocarcinoma

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05185869
• Other study ID #: PANC-1st-IIT-SHR6390-AG
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: January 2022
• Est. completion date: October 2025

Study information

• Verified date: October 2021
• Source: Ruijin Hospital
• Contact: Baiyong Shen, Ph.D&M.D
• Phone: 008613901943778
• Email: shenby[@]shsmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study is being conducted to evaluate the efficacy, safety and tolerability of SHR6390 in combination with nab-paclitaxel and gemcitabine in first-line treatment of subjects with advanced/metastatic pancreatic cancer.

Description:

This is an open-label, prospective, single-center, single-arm, Simon's two-stage design phase II study for unresectable advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) subjects treated with SHR6390 plus nab-paclitaxel and gemcitabine. In this research study, the main objectives include: 1. Evaluate objective response rate in patients with pancreatic cancer receiving SHR6390 plus nab-paclitaxel and gemcitabine. 2. Assess adverse side effects associated with the combination of SHR6390 with nab-paclitaxel and gemcitabine.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 58
• Est. completion date: October 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Male or female of 18 to 75 years old;

2. Subjects are diagnosed with histologically confirmed unresectable advanced or metastatic pancreatic ductal adenocarcinoma with at least one measurable lesion according to the RECIST 1.1 standard (the CT scan length of the tumor lesion > 10 mm);

3. Subjects are naïve to systemic treatment;

4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;

5. Life expectancy =12 weeks;

6. Adequate organ performance based on laboratory blood tests;

7. The toxicity of the previous treatment has been restored to =1 level (if there is surgery, the wound has completely healed);

8. Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation;

9. Normal swallowing function;

10. 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:

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

2. Confirmed or suspicious new metastatic lesion in brain;

3. Subjects are allergy to experimental drugs or any excipients;

4. Coagulation disorders (INR>1.5, APTT>ULN);

5. Severe pleural effusion or ascites;

6. Severe and uncontrolled medical diseases, acute infections; recent history of major surgery for myocardial infarction (within 3 months);

7. Subjects combined with other anti-tumor drugs;

8. Chronic diarrhea or intestinal obstruction;

9. Pregnant or lactating women; Fertile subjects who are unwilling or unable to take effective contraceptive measures;

10. Subjects in any trial drug treatment;

11. Severe mental disorder;

12. Other situations that investigators considered should be excluded.

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• SHR6390
SHR6390, Oral Administration
• Nab-paclitaxel
Paclitaxel-albumin, Intravenous Injection
• Gemcitabine
Gemcitabine, Intravenous Injection

Locations

Country	Name	City	State
China	Ruijin Hospital Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate (ORR)	ORR is defined as the proportion of patients with best objective response of confirmed complete response (CR) or partial response (PR) according to RECIST1.1.	Up to 2 years.
Primary	Adverse Events (AEs)	AEs were graded according to the National Cancer Institute's Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0.	From the first drugs administration to within 30 days for the last treatment.
Secondary	Overall Survival (OS)	OS is defined as the time from the first drugs administration to the date of death due to any cause or the last follow ship.	Up to 2 years.
Secondary	Progression Free Survival (PFS)	PFS is defined as the time from the first drugs administration to the date of disease progression or the last follow ship.	Up to 2 years.
Secondary	Disease Control Rate (DCR)	DCR is defined as the rate of participants who have achieved complete response, partial response and stable disease.	Up to 2 years.