Nab-paclitaxel Plus PD-1 Inhibitor Versus Nab-paclitaxel as Second-line Treatment in Advanced Gastric Cancer

A Multi-center, Open-label, Randomized Controlled Clinical Study of Nab-paclitaxel Plus SHR-1210(PD-1 Inhibitor)Versus Nab-paclitaxel as Second-line Treatment in Advanced or Recurrent Gastric and Esophagogastric Adenocarcinoma

This is a Multi-center, Open-label, Randomized Controlled,phase 2 clinical trail of Albumin-bound Paclitaxel Plus SHR-1210 （PD-1 inhibitor）Versus Albumin-bound Paclitaxel as Second-line Treatment in Advanced or Recurrent Gastric Adenocarcinoma

Study Overview

• Status: Active, not recruiting
• Conditions: Gastric Cancer; GastroEsophageal Cancer
• Intervention / Treatment: Drug: Albumin-bound Paclitaxel Plus SHR-1210 (PD-1 inhibitor); Drug: Albumin-bound Paclitaxel

Detailed Description

This is a Multi-center, Open-label, Randomized Controlled,phase 2 clinical trail of an immune checkpoint inhibitor in patients with advanced or recurrent gastric and esophagogastric junction adenocarcinoma, including two arms to compare the efficacy and safety of Albumin-bound Paclitaxel Plus SHR-1210 （PD-1 inhibitor）regimen and Albumin-bound Paclitaxel single-agent regimen in second-line treatment.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Xianglin Yuan, MD,PHD; Phone Number: 8627-83663406; Email: xlyuan1020@163.com
• Study Contact Backup: Name: li sun, MD,PHD; Phone Number: 8615072420205; Email: litchisun@163.com

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age of 18-70 years.
2. Second line treatment for cytological or histological diagnosis of recurrent or metastatic gastric and esophagogastric adenocarcinoma. Disease progression after adjuvant therapy within 6 months is eligible.
3. ECOG performance status of 0-2.
4. Estimated life expectancy of at least 3 months.
5. Bone marrow function: white blood cell count≥3.0×109 /L, absolute neutrophil count(ANC) ≥1.5×109 /L, platelet count(PLT) ≥90×109 /L, hemoglobin(HB) ≥90 g/L.
6. Left ventricular ejection fraction (LVEF) ≥ 50%.
7. Liver and kidney function: Creatinine(Cr)≤1.5 x upper limit of normal range(ULN); alanine glutamate transaminase (ALT) and glutamate transaminase (AST) ≤2.5 x upper limit of normal range (ULN), or ≤5 x upper limit of normal range (ULN)when with hepatic metastases，total bilirubin (TBIL)≤1.5 x upper limit of normal range (ULN), or≤2.5 x upper limit of normal range (ULN) when with Gilbert's syndrome.
8. Any acute, clinically significant treatment-related toxicity caused by previous treatment must have been reduced to less than or equal to grade 1, except hair loss.
9. Able and willing to comply with the study plans in this protocol and sign the informed consent.

Exclusion Criteria:

1. uncontrollable infections or have received systematic antibiotic treatment within 72 hours before enrollment.
2. Any abnormal bone marrow hyperplasia or other abnormal hematopoietic function.
3. Have a second malignancy within 5 years prior to registration except for cured carcinoma in situ of cervix uteri, non-melanoma skin cancer.
4. Patients with symptomatic brain metastases.
5. Allergic to the chemotherapy drugs or the materials in this study.
6. Suffering from mental or nervous system disorders and unable to cooperate.
7. Pregnant or nursing female patients. Men and women of reproductive age are unwilling to take reliable contraceptive measures during the study.
8. Active autoimmune disease, history of autoimmune disease, use of corticosteroids or immunosuppressants, or use of hormone replacement therapy, such as thyroxine, insulin, etc.
9. Live vaccine was administered within 30 days before enrolment (injectable seasonal influenza vaccine is allowed as it is inactivated).
10. Patients with other diseases not suitable for enrolment, such as active tuberculosis, hepatitis B (after treatment, hepatitis B virus titer HBV-DNA <500IU/ml, and liver function is normal, but cannot be combined with hepatitis C), hepatitis C, uncontrolled electrolyte disorders ,pericardial effusion, pleural effusion and abdominal effusion, etc.
11. Have participated in other clinical trials within 30 days prior to this study.
12. History of organ transplantation.
13. Patients that researcher consider cannot sign informed consent or complete the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nab-P/PD-1; Patients in this arm receive albumin-bound paclitaxel and SHR-1210 (PD-1 inhibitor) thepary.	Drug: Albumin-bound Paclitaxel Plus SHR-1210 (PD-1 inhibitor); Albumin-bound Paclitaxel 100 mg/m2,ivdrip,d1,d8,d15,Q28d,or Albumin-bound Paclitaxel 125-130 mg/m2,ivdrip,d1,d8,Q21d,or Albumin-bound Paclitaxel 260mg/m2,ivdrip,d1,Q21d;SHR-1210 200mg, ivdrip,d1,Q21d.
Active Comparator: Nab-P; Patients in this arm receive albumin-bound paclitaxel single-agent chemotherapy.	Drug: Albumin-bound Paclitaxel; Albumin-bound Paclitaxel 100 mg/m2,ivdrip,d1,d8,d15,Q28d,or Albumin-bound Paclitaxel 125-130 mg/m2,ivdrip,d1,d8,Q21d,or Albumin-bound Paclitaxel 260mg/m2,ivdrip,d1,Q21d;

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
objective response rate(ORR)	The rate of participants that achieve either a complete response (CR) or a partial response (PR).Higher rate of ORR indicates better treatment effect.	up to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free Survival (PFS)	Time from the start of treatment to progression of disease or death.Higher rate of 9m PFS in statistic analysis means better outcome.	up to 9 months
Overall survival (OS)	Time from the start of treatment until death due to any reason.Increased rate of 12m OS compared to the other arm indicates more benefit from the treatment regimen.	up to 12 months
Safety as measured by number and grade of adverse events	Summary adverse events according to NCI-CTCAE 5.0	up to 12 months
patient-reported outcomes (PROs)	Patient-reported outcomes according to EQ-5D questionnaires.	up to 12 months

Collaborators and Investigators

• Sponsor: Huazhong University of Science and Technology
• Investigators: Study Chair: Xianglin Yuan, MD,PhD, oncology center of Tongji Hospital,wuhan,China

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2020
• Primary Completion (Anticipated): March 31, 2023
• Study Completion (Anticipated): June 30, 2023

Study Registration Dates

• First Submitted: March 2, 2020
• First Submitted That Met QC Criteria: March 2, 2020
• First Posted (Actual): March 4, 2020

Study Record Updates

• Last Update Posted (Actual): January 25, 2023
• Last Update Submitted That Met QC Criteria: January 21, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Gastric cancer; PD-1 inhibitor; GastroEsophageal Cancer; Albumin-bound Paclitaxel
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel; Albumin-Bound Paclitaxel; Immune Checkpoint Inhibitors
• Other Study ID Numbers: TJCC011

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No