Safety and Efficacy of Leucine-Restricted Diet Combined With Neoadjuvant Chemotherapy and Immunotherapy in Gastric Cancer
Recruiting
Phase 2
Interventional Study
Gastric Cancer
Leucine-restricted Diet
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 70
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 108 (estimated)
- Sponsor
- Qilu Hospital of Shandong University · Other
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About This Trial
Consistent with previous literature, the investigators postulate that a leucine-restricted diet is safe and well-tolerated in gastric cancer patients receiving neoadjuvant chemo-immunotherapy. Furthermore, the investigators propose that this dietary regimen promotes the activation of immune cells within the tumor microenvironment (TME). When combined with neoadjuvant chemo-immunotherapy, it demons…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Pathological Confirmation: Histologically confirmed locally advanced gastric cancer.
* Demographics: Aged 18 to 70 years, inclusive, regardless of gender.
* Dietary Capability: Capable of oral intake or receiving a liquid diet via nasogastric tube.
* Consent: Willing to partic…
Contacts