Durvalumab with FLOT before and after surgery for resectable gastric/GEJ cancer in Chinese patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 3, randomized study comparing neoadjuvant-adjuvant durvalumab plus FLOT to neoadjuvant-adjuvant placebo plus FLOT, followed by adjuvant durvalumab or placebo in Chinese patients with resectable GC/GEJC. About 140 participants will be randomized to the two arms. Primary goals are to assess safety and efficacy of the durvalumab-containing regimen in this perioperative setting. Treatments include the standard FLOT chemotherapy regimen with or without durvalumab, given around surgery and then continued postoperatively in the respective arm. The study builds on the global MATTERHORN data and focuses on feasibility and potential benefit in a Chinese population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 1\. Capable of giving signed informed consent. 2. Male and/or Female, Age ≥ 18 years at the time of screening. 3. Histologically documented gastric or gastroesophageal junction adenocarcinoma with resectable disease, GEJC includes Siewert\* type 2 and 3 tumour and Siewert\* type 1 tumour.

  1. Per the judgment of the Investigator, participants must be medically fit for treatment with neoadjuvant FLOT therapy prior to radical surgery.
  2. At screening, complete surgical resection of the primary GC/GEJC must be deemed achievable, as assessed by a multidisciplinary evaluation, which must include a board certified GI surgeon.
  3. No prior anti-cancer therapy (eg, chemotherapy, radiation therapy, or chemoradiation therapy) for the current malignancy.

     4\. ECOG PS of 0 or 1 with no deterioration over the previous 2 weeks prior to baseline at screening and prior to randomization.

     5\. Adequate organ and marrow function as defined below:

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  1. Haemoglobin ≥ 9.0 g/dL
  2. Absolute neutrophil count ≥ 1.5 × 109/L
  3. Platelet count ≥ 100 × 109/L
  4. Serum bilirubin ≤ 1.5 ×ULN. This will not apply to participants with confirmed Gilbert's syndrome, who will be allowed in consultation with their physician.
  5. ALT and AST ≤ 2.5 × ULN
  6. Measured CL \> 50 mL/min or Calculated CL \> 50 mL/min as determined by Cockcroft-Gault (using actual body weight) 6. Must have a life expectancy of at least 24 weeks. 7. Body weight \> 30 kg at enrolment and randomization. 8. Meeting tumour sample requirements (at screening) to confirm PD-L1 status.

Exclusion Criteria:

* -1. Participants with peritoneal dissemination (including tumour cells in peritoneal fluid) or distant metastasis.

  2\. Participants with adenosquamous cell carcinoma, squamous cell carcinoma, or GI stromal tumour.

  3\. History of allogeneic organ transplantation. 4. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \[eg, colitis or Crohn's disease\], systemic lupus erythematosus, sarcoidosis, granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc), autoimmune pneumonitis, and autoimmune myocarditis.

  5\. Uncontrolled intercurrent illness that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent.

  6\. History of another primary malignancy except for

  (a) Malignancy treated with curative intent and with no known active disease ≥ 2 years before the first dose of study intervention and of low potential risk for recurrence (b) Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease (c) Adequately treated carcinoma in situ without evidence of disease 7. History of active primary immunodeficiency. 8. Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis testing in line with local practice) and HIV verified by positive HIV-1 or HIV-2 antibodies.

  9\. Mean QTc ≥ 470 ms calculated from 3 ECGs (within 15 minutes at 5 minutes apart).

  10\. Known allergy or hypersensitivity to any of the study interventions or any of the study intervention excipients.

Where it's running

• Research Site
  Beijing, China Recruiting
• Research Site
  Changchun, China Recruiting
• Research Site
  Chengdu, China Recruiting
• Research Site
  Hangzhou, China Recruiting
• Research Site
  Jinan, China Recruiting
• Research Site
  Lanzhou, China Recruiting

Study contacts

• Study coordinator: AstraZeneca Clinical Study Information Center
• Email: information.center@astrazeneca.com
• Phone: 1-877-240-9479

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Neoadjuvant trastuzumab, durvalumab, and FLOT for HER2-positive gastric or GEJ cancer

  This study tests a pre-surgery treatment combining trastuzumab, durvalumab, and FLOT for patients with HER2-positive locally advanced gastric or gastroesophageal junction cancer to see how many achieve complete tumor disappearance.

  Recruiting Phase 2 Samsung Medical Center · Seoul, Gang-Nam · NCT07911280

• Zolbetuximab added to FLOT and durvalumab before surgery for CLDN18.2-positive gastric/GEJ cancer

  This study tests whether adding zolbetuximab to FLOT chemotherapy plus durvalumab can improve tumor response before surgery in adults with CLDN18.2-positive gastric or GEJ cancer.

  Recruiting Phase 2 National Cancer Center, Japan · Saitama and 3 other locations · NCT07872722

• Alternating chemo-immunotherapy and FGFR inhibitor for FGFR-positive biliary tract cancer

  This phase 2 trial tests whether alternating gemcitabine/cisplatin with durvalumab and the FGFR2 inhibitor pemigatinib can help people with unresectable or metastatic biliary tract cancers that have FGFR alterations.

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• Futibatinib and immunotherapy with chemo as first-line treatment for advanced biliary tract cancer

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• Adjuvant durvalumab with GEMOX/GC chemotherapy followed by lenvatinib vs capecitabine in biliary tract cancer after surgery

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.