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

NCT ID: NCT05185869

Last Updated: 2022-01-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-31
• Study Completion Date: 2025-10-31

Brief 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.

Detailed 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.

Conditions

Pancreatic Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AG+SHR6390

Subjects will receive SHR6390 plus nab-paclitaxel and gemcitabine

Group Type: EXPERIMENTAL

SHR6390

Intervention Type: DRUG

SHR6390, Oral Administration

Nab-paclitaxel

Intervention Type: DRUG

Paclitaxel-albumin, Intravenous Injection

Gemcitabine

Intervention Type: DRUG

Gemcitabine, Intravenous Injection

Interventions

SHR6390

SHR6390, Oral Administration

Intervention Type: DRUG

Nab-paclitaxel

Paclitaxel-albumin, Intravenous Injection

Intervention Type: DRUG

Gemcitabine

Gemcitabine, Intravenous Injection

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ruijin Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ruijin Hospital Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

Countries

China

Central Contacts

Baiyong Shen, Ph.D&M.D

Role: CONTACT

shenby@shsmu.edu.cn

008613901943778

Facility Contacts

Baiyong Shen, Ph.D&M.D

Role: primary

008602164370045

Other Identifiers

PANC-1st-IIT-SHR6390-AG

Identifier Type: -

Identifier Source: org_study_id