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Camrelizumab Combined with Apatinib Mesylate Tablets, Nab-paclitaxel and S-1 in the Treatment of Locally Advanced Gastric Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Camrelizumab Combined with Apatinib Mesylate Tablets, Nab-paclitaxel and S-1 in the Treatment of Locally Advanced Gastric Cancer

Camrelizumab Combined with Apatinib Mesylate Tablets, Nab-paclitaxel and S-1 in the Treatment of Locally Advanced Gastric Cancer: an Multicenter, Open, Randomized, Controlled Clinical Study

NCT04195828•Fujian Medical University

View on ClinicalTrials.gov

Summary

To evaluate the clinical efficacy and safety of camrelizumab combined with apatinib mesylate, nab-paclitaxel and S-1

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Age: 18-75 years of age
•Gastric adenocarcinoma was confirmed by pathology（ including histology or cytology）。
•CT/MRI,PET-CT or laparoscopic exploration were used to confirm the diagnosis of gastric cancer staging as cT2-4a and/or N+ and M0 before operation.
•measurable lesions at least should be detected by CT/MRI examination in accordance with the RECIST1.1.（CT scan of tumor lesion length≥10mm，CT scan short diameter≥15mm，scan slice thicknes 5mm）
•ECOG（Eastern Cooperative Oncology Group）PS（Performance Status）:0-1 scores;
•the expected survival time is more than 12 weeks
•the main organ function is normal, which should meet the following criteria:
•(1) blood routine examination standards should be met（no blood transfusion within 14 days）
•a．HB≥ 100g/L b. WBC≥3×109/L c. ANC≥1.5×109/L d. PLT≥100×109/L （2）biochemical examination shall comply with the following criteria：
•1. BIL\<1.5 normal upper limit ULN
+5 more criteria

Exclusion Criteria

•Previous history of chemotherapy, radiotherapy, targeted drug therapy or immunotherapy
•Patients with contraindications for surgical treatment and chemotherapy or whose physical condition and organ function do not allow for larger abdominal surgery
•patients with metastasis
•Having any active autoimmune diseases or a history of autoimmune diseases (such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases or syndromes); Patients with vitiligo or cured childhood asthma/allergies who did not need any intervention in adulthood were excluded; Autoimmune hypothyroidism treated with a stable dose of thyroid replacement hormone; Type 1 diabetes with stable doses of insulin
•A history of immunodeficiency, including HIV testing positive, or other acquired or congenital immunodeficiency disorders, or a history of organ transplantation and allogeneic bone marrow transplantation
•Accompanied by serious heart, lung, liver, kidney disease; Have nerve, mental disease; Jaundice or obstruction of the digestive tract with severe infection
•pregnant or lactating women
•The blood pressure of patients with hypertension cannot be reduced to the normal range by the antihypertensive drugs (systolic pressure \>140 mmHg, diastolic pressure \>90 mmHg)
•With Ⅰ magnitude of coronary heart disease, arrhythmia (including QTc protracted between male \> 450 ms, women \> 470 ms) and cardiac insufficiency
•Patients have a clear tendency with gastrointestinal bleeding, including the following situation: local active ulcerative lesions, and fecal occult blood (+ +); with melena and hematemesis history in 2 months; and patients with fecal occult blood (+) and unresected gastric primary tumor; patients with the risk of bleeding should take the gastroscopy test, if it is the gastric cancer, and researchers believe that may results in massive digestive tract hemorrhage；coagulation dysfunction (INR(international normalized ratio)\>1.5, APTT(activated partial thromboplastin time)\>1.5 ULN), with bleeding tendency;
+5 more criteria

Locations (1)

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Key Dates

Start Date

June 18, 2020

Primary Completion Date

July 22, 2022

Completion Date

March 24, 2025

Last Updated

April 1, 2025

Enrollment

106

ACTUAL participants

Conditions

Advanced Gastric Cancer

Interventions

Camrelizumab

DRUG

Apatinib Mesylate

DRUG

nab-paclitaxel

DRUG

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RECRUITINGPHASE2

Safety and Efficacy of SHR2554 Combined With Other Antitumor Therapies in Gastric or Gastro-oesophageal Junction Adenocarcinoma

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 1, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Camrelizumab Combined with Apatinib Mesylate Tablets, Nab-paclitaxel and S-1 in the Treatment of Locally Advanced Gastric Cancer

Inclusion Criteria

Exclusion Criteria

Optimal Methods to Characterize ADC Resistance in Solid Tumors and Identify Clinically Useful Biomarkers

Safety and Efficacy of SHR2554 Combined With Other Antitumor Therapies in Gastric or Gastro-oesophageal Junction Adenocarcinoma

First-Line and Neoadjuvant Immunotherapy for Gastric Cancer

Machine Learning-driven Noninvasive Screening of Transcriptomics Liquid Biopsies for Early Diagnosis of Occult Peritoneal Metastases in Locally Advanced Gastric Cancer

SHR-A1811 for Subjects With Her2-positive Gastric Cancer and Gastroesophageal Junction Adenocarcinoma After Progression on or After First-line Anti-HER2 Therapy-containing Regimen

Evaluation of Pressurized Intraperitoneal Aerosol Chemotherapy With VRT106 Versus PIPAC in Patients With Advanced Gastric Cancer and PeritonealMetastasis: A Prospective, Multicenter, Open-Label, Randomized Controlled Trial