Camrelizumab Combined With Albumin-bound Paclitaxel and S-1 in the Treatment of Advanced Gastric Cancer

NCT04675866 | Unknown

• 1 other identifier: YXGC-001
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the safety and efficacy of Camrelizumab combined with paclitaxel (albumin binding type) and S-1 for first-line treatment of advanced gastric cancer, and to further explore the curative effect of PD - L1 expression in tumor tissue, EBV virus content, microsatellite instability (MSI), DNA mismatch repair (MMR), tumor mutation load (TMB), lymphocyte subgroup and cytokines.

Conditions

Advanced Gastric Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  Defined as the proportion of patients with a documented complete response, and partial response (CR+PR).

  up to 2 years

Secondary Outcomes (3)

• Disease control rate (DcR)

  up to 2 years

• Overall survival (OS)

  up to 2 years

• Progression free survival (PFS)

  up to 2 years

Study Arms (1)

camrelizumab+albumin-bound paclitaxel+S-1

EXPERIMENTAL

camrelizumab+albumin-bound paclitaxel+S-1

Other: Camrelizumab, Albumin-bound paclitaxel, S-1

Interventions

Camrelizumab, Albumin-bound paclitaxel, S-1 OTHER

Camrelizumab: 200mg, iv, Q3W, d1; Albumin-bound paclitaxel: 125mg/m2, iv, d1, 8, Q3W; S-1: According to the patient's body surface area, the dosage is set to 40, 50, 60 mg/time, bid, po, taking 2 weeks, and stopping the drug for 1 week as a cycle.

camrelizumab+albumin-bound paclitaxel+S-1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-75 years old, no gender limit.
• ECOG 0-1; estimated survival time ≥12 weeks.
• Histopathologically confirmed unresectable locally advanced or metastatic HER-2 negative gastric adenocarcinoma.
• At least one measurable lesion (RECIST1.1 standard).
• Have not received systemic treatment for inoperable or metastatic gastric adenocarcinoma, past (new) adjuvant chemotherapy and adjuvant radiotherapy treatment ended to enrollment\> 6 months.
• For local lesions (non-target lesions) palliative treatment (mainly local radiotherapy) end time to random entry time\> 2 weeks.
• The main organs and bone marrow function are basically normal:
• Routine blood: neutrophils ≥1.5×109/L, platelets ≥100×109/L, hemoglobin ≥80g/L;
• Liver function: TBiL≤1.5×ULN; ALT/AST≤2.5×ULN (for patients with liver metastases, ≤5ULN);
• Renal function: serum creatinine≤1.5×ULN and creatinine clearance rate\>60mL/min;
• INR≤1.5×ULN and activated partial thromboplastin time ≤1.5×ULN.
• Voluntary participation in the clinical study; fully understands and is informed of the study and has signed the Informed Consent Form (ICF); willing to comply with and able to complete all trial procedures.
• Female subjects of childbearing age or male subjects whose sexual partners are females of childbearing age shall take effective contraceptive measures throughout the treatment period and 6 months after the treatment period.

You may not qualify if:

• Patients who have previously been treated with albumin-bound paclitaxel or paclitaxel.
• Received major surgery (craniotomy, thoracotomy or laparotomy), open biopsy or major traumatic injury within 28 days before enrollment, or expected major surgery during the study treatment period.
• Suffered from other malignant tumors in the past 5 years (except for cured skin basal cell or squamous cell carcinoma, or carcinoma in situ such as cervix and breast).
• The investigator believes that it will affect the subjects' ability to receive the treatment of the study protocol and are not controlled for serious medical diseases, such as combined serious medical diseases, including severe heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled high blood pressure, Active peptic ulcer, severe infection, etc.
• Symptomatic congestive heart failure or cardiac color Doppler ultrasound examination shows LVEF (left ventricular ejection fraction \<50%).
• Any arterial thromboembolic events, including unstable angina pectoris and cerebrovascular accidents, occurred within 6 months before being selected for treatment.
• A history of deep vein thrombosis, pulmonary embolism or any other serious thromboembolism within 3 months before enrollment.
• Participate in other clinical trials 28 days before enrollment, unless participating in observational (non-interventional) clinical research or in the follow-up phase of interventional research.
• Patients with a history of interstitial lung disease, non-infectious pneumonia, or active tuberculosis.
• Patients with congenital or acquired immune deficiency, active hepatitis B or C.
• The patient is using immunosuppressive agents or systemic hormone therapy to achieve immunosuppressive purposes. Those who are still using it within 2 weeks before enrollment.
• Patients with difficult-to-control effusion, accompanied by severe pleural effusion, abdominal effusion and other clinical symptoms.
• Patients with grade ≥ 2 sensory or motor neuropathy; patients with peripheral neuropathy NCT-CTCAE ≥ 2.
• People with a history of psychotropic drug abuse and unable to quit or patients with mental disorders.

Sponsors & Collaborators

• Henan Cancer Hospital: lead

Study Sites (1)

Henan Tumor Hospital

Luoyang, Henan, 450000, China

RECRUITING

Related Publications (1)

• Wu C, Li S, Hou X. Camrelizumab plus albumin-bound paclitaxel and S-1 as first-line treatment for patients with human epidermal growth factor receptor 2-negative advanced gastric or gastroesophageal junction adenocarcinoma: a phase 2 trial. Front Immunol. 2026 Jan 2;16:1634502. doi: 10.3389/fimmu.2025.1634502. eCollection 2025.

  PMID: 41550955 DERIVED

MeSH Terms

Interventions

camrelizumab; Albumin-Bound Paclitaxel; S 1 (combination)

Intervention Hierarchy (Ancestors)

Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Physician

Study Record Dates

• First Submitted: December 14, 2020
• First Posted: December 19, 2020
• Study Start: August 17, 2020
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: April 15, 2022

Record last verified: 2021-11

Locations

CN (1)