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

NCT ID: NCT04294784

Last Updated: 2024-11-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-03
• Study Completion Date: 2023-11-30

Brief Summary

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

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.

Conditions

Gastric Cancer; GastroEsophageal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Nab-P/PD-1

Patients in this arm receive albumin-bound paclitaxel and SHR-1210 (PD-1 inhibitor) thepary.

Group Type: EXPERIMENTAL

Albumin-bound Paclitaxel Plus SHR-1210 (PD-1 inhibitor)

Intervention Type: DRUG

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.

Nab-P

Patients in this arm receive albumin-bound paclitaxel single-agent chemotherapy.

Group Type: ACTIVE_COMPARATOR

Albumin-bound Paclitaxel

Intervention Type: DRUG

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;

Interventions

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.

Intervention Type: 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;

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Huazhong University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Xianglin Yuan

Professor, Head of the cancer center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xianglin Yuan, MD,PhD

Role: STUDY_CHAIR

oncology center of Tongji Hospital,wuhan,China

Locations

Tongji hospital of Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Countries

China

References

Sun L, Gong Z, Wang L, Kuang L, Huang Q, Pei B, Yuan X, Qiu H. Multi-center phase II study of nab-paclitaxel plus camrelizumab versus nab-paclitaxel alone as second-line treatment for advanced gastric cancer. Oncologist. 2025 Jul 4;30(7):oyaf189. doi: 10.1093/oncolo/oyaf189.

Reference Type: DERIVED

PMID: 40554667 (View on PubMed)

Other Identifiers

TJCC011

Identifier Type: -

Identifier Source: org_study_id