CAPOX + Bevacizumab + Tislelizumab Treating PD-L1 CPS < 5 Locally Advanced or Metastatic GEA

Last updated: March 14, 2025
Sponsor: Chinese PLA General Hospital
Overall Status: Completed

Phase

2

Condition

Adenocarcinoma

Treatment

CAPOX combined with bevacizumab and Tislelizumab

Clinical Study ID

NCT05299476
S2021-642-01
  • Ages > 18
  • All Genders

Study Summary

his study was a single-arm, open, single-center Phase ii clinical trial to observe and evaluate the efficacy and safety of CAPOX+ bevacizumab + tislelizumab in first-line treatment of ADVANCED gastroesophageal adenocarcinoma with CPS < 5.

This study targeted advanced gastric cancer patients who could not undergo radical treatment, who had not received systemic therapy before, or who had recurrence and metastasis more than 6 months after the end of adjuvant therapy.

The 6-month progression-free survival (PFS) rate will be used as the primary outcome indicator, and approximately 30 subjects will be enrolled.

Subject will receive CAPOX+ bevacizumab + tislelizumab continuously for a treatment cycle of 3 weeks after fully informed and signing informed consent, oxaliplatin will be stopped after 4-8 cycles, and other drugs will continue to be used until the treatment interruption event specified in the plan occurs. Post-treatment follow-up for safety and survival will continue after completion of treatment, and follow-up for tumor progression will also be conducted after completion of treatment for subjects who have not finished treatment for a cause of disease progression/death.

After the subjects were enrolled in the study, safety visits were conducted for each treatment cycle D1 before medication. Imaging will be performed every 2 cycles from the first year of treatment to assess efficacy, and every 3 cycles after 1 year until treatment ends, informed consent is withdrawn, or death.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • At the same time, patients voluntarily participated in the study and signed informedconsent.

  • Either male or female, aged 18 or older.

  • Patients diagnosed by pathological or cytological diagnosis of gastric cancer (GC),gastroesophageal junction carcinoma (GEJ) or esophageal adenocarcinoma had evidenceof local advanced lesions or metastases that could not be surgically resected, andwere mostly adenocarcinoma confirmed by histological examination.

  • Anyway, she has no previous systemic therapy; Or had received neoadjuvant/adjuvantchemotherapy but experienced disease progression or recurrence 6 months after theend of treatment;

  • PDL-1 CPS < 5, HER2 negative;

  • Anyway, ECOG scores 0-1 on PS.Estimated survival ≥3 months;

  • Anyway, their vital organs function according to the following rules:

  1. Hemoglobin (HGB) ≥90g/L;

  2. Neutrophil count (ANC) ≥1.5×109/L;

  3. Platelet count (PLT) ≥80×109/L;

  4. ALT and AST≤2.5×ULN;ALT and AST≤5×ULN for liver metastasis;

  5. Total bilirubin (TBIL) ≤1.5 times normal upper limit (ULN);

  6. Serum Cr≤1×ULN, endogenous creatinine clearance rate > 50ml/min (Cockcroft-Gault formula);

  7. Urinary protein < (++), or 24-hour urinary protein < 1.0g;

  • Lent blood functions normally, without active bleeding or thrombotic disease:
  1. INR≤1.5×ULN;

  2. Partial thrombin time APTT≤1.5×ULN;

  3. Prothrombin time PT≤1.5×ULN;

  • Women of reproductive age had to undergo a pregnancy test (serum or urine) which wasnegative within 7 days of enrollment, and volunteer to use an appropriate method ofcontraception during the observation period and for 12 weeks after the last studydrug was given. For men, surgical sterilization or consent to use appropriatemethods of contraception during the observation period and for 12 weeks after thelast administration of the study drug;

  • Anyway, people who comply are expected to be able to follow up on therapeuticoutcomes and adverse reactions as required by the regimen.

Exclusion

Exclusion Criteria:

  • Five years before first use of the study drug has been diagnosed as other malignanttumor, the effective treatment of basal cell carcinoma, squamous cell carcinoma ofthe skin and/or the effective removal of cervical cancer in situ and/or exceptbreast cancer.

  • Known allergy to oxaliplatin, PD-1 mab, bevacizumab or pharmaceutical excipients;Orsevere allergic reactions to other monoclonal antibodies;

  • Chauvinist has any active autoimmune disease or a history of autoimmune disease (e.g. interstitial pneumonia, uveitis, enteritis, hepatitis,hypophysitis,vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (which can be included after hormone replacement therapy); Patients with completeremission of childhood asthma without intervention or vitiligo as adults may beincluded, but not those requiring medical intervention with bronchodilators;

  • HBV DNA>500 IU/ mL (or 2000 copies /ml), HCV RNA>103 copies /ml, HBsAg+ and anti-HCVantibody positive;

  • Lent has a history of HIV infection;

  • Accuser spends 14 days prior to first using a study drug, regardless of nasal sprayand inhaled corticosteroids or physiological doses of systemic steroids (i.e., nomore than 10 mg/ day of prednisone or an equivalent pharmacophysiological dose ofanother corticosteroid);

  • A live attenuated vaccine was administered either four weeks before the first doseor during the study period;

  • History of allogeneic organ transplantation or allogeneic hematopoietic stem celltransplantation is known;

  • Hypertension that cannot be controlled even with standard treatment (systolic blood ≥160mmHg/ diastolic blood pressure ≥100mmHg);

  • Either having poorly controlled cardiac clinical symptoms or disease, such as :(1)NYHA grade 2 or higher heart failure, (2) unstable angina, (3) myocardial infarctionwithin 1 year, or (4) clinically significant supracventricular or ventriculararrhythmias requiring treatment or intervention;

  • Patients at risk of serious bleeding, including but not limited to severe bleeding (bleeding > 30 ml within 3 months), were evaluated by a physician who agreed tospend time on an endoscopic evaluation, which was subject to endoscopic evaluation.

  • Either a thromboembolic event (including a stroke event and/or a transient ischemicattack) occurs within 6 months;

  • Participates in another clinical trial, or participates in any other drug clinicalstudy within four weeks, or at least five half-lives since the last study drug wastaken;

  • At the same time, participants in the Study underwent anti-tumor therapy includingchemotherapy, radiotherapy and immunotherapy within 4 weeks prior to drugadministration.

  • At the same time, participants received palliative radiotherapy for bone metastasiswithin 2 weeks prior to the beginning of drug administration. Radiation therapy forother sites within the first 4 weeks;

  • Regardless, toxicity from previous anti-tumor therapy does not return to CTCAE [version 5.0] level 0-1, as shown in the following.Except: a. hair loss;B.Pigmentation;C. Long-term toxicity caused by radiotherapy could not be recoveredaccording to the judgment of researchers;

  • Other conditions that the investigator deems inappropriate for inclusion;

Study Design

Total Participants: 32
Treatment Group(s): 1
Primary Treatment: CAPOX combined with bevacizumab and Tislelizumab
Phase: 2
Study Start date:
April 25, 2022
Estimated Completion Date:
January 20, 2025

Connect with a study center

  • Chinese PLA General Hospital

    Beijing,
    China

    Site Not Available

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