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

NCT04294784 | Terminated Phase 2

• 1 other identifier: TJCC011
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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

Conditions

Gastric Cancer; GastroEsophageal Cancer

Keywords

Gastric cancer; GastroEsophageal Cancer; Albumin-bound Paclitaxel; PD-1 inhibitor

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Progression-free Survival (PFS)

  up to 9 months

• Overall survival (OS)

  up to 12 months

• Safety as measured by number and grade of adverse events

  up to 12 months

• patient-reported outcomes (PROs)

  up to 12 months

Study Arms (2)

Nab-P/PD-1

EXPERIMENTAL

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)

Nab-P

ACTIVE COMPARATOR

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

Drug: Albumin-bound Paclitaxel

Interventions

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

Albumin-bound Paclitaxel 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;

Nab-P

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age of 18-70 years.
• 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.
• ECOG performance status of 0-2.
• Estimated life expectancy of at least 3 months.
• 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.
• Left ventricular ejection fraction (LVEF) ≥ 50%.
• 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.
• 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.
• Able and willing to comply with the study plans in this protocol and sign the informed consent.

You may not qualify if:

• uncontrollable infections or have received systematic antibiotic treatment within 72 hours before enrollment.
• Any abnormal bone marrow hyperplasia or other abnormal hematopoietic function.
• Have a second malignancy within 5 years prior to registration except for cured carcinoma in situ of cervix uteri, non-melanoma skin cancer.
• Patients with symptomatic brain metastases.
• Allergic to the chemotherapy drugs or the materials in this study.
• Suffering from mental or nervous system disorders and unable to cooperate.
• Pregnant or nursing female patients. Men and women of reproductive age are unwilling to take reliable contraceptive measures during the study.
• Active autoimmune disease, history of autoimmune disease, use of corticosteroids or immunosuppressants, or use of hormone replacement therapy, such as thyroxine, insulin, etc.
• Live vaccine was administered within 30 days before enrolment (injectable seasonal influenza vaccine is allowed as it is inactivated).
• 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.
• Have participated in other clinical trials within 30 days prior to this study.
• History of organ transplantation.
• Patients that researcher consider cannot sign informed consent or complete the study.

Sponsors & Collaborators

• Huazhong University of Science and Technology: lead

Study Sites (1)

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

Wuhan, Hubei, 430030, China

Location

Related Publications (1)

• 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.

  PMID: 40554667 DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Albumin-Bound Paclitaxel; camrelizumab; Immune Checkpoint Inhibitors

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses

Study Officials

• Xianglin Yuan, MD,PhD

  oncology center of Tongji Hospital,wuhan,China

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Head of the cancer center

Study Record Dates

• First Submitted: March 2, 2020
• First Posted: March 4, 2020
• Study Start: April 3, 2020
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2023
• Last Updated: November 4, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)