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Neoadjuvant Tislelizumab + LM-302 + S-1 or Tislelizumab + SOX for CLDN18.2-Positive Gastric/GEJ Adenocarcinoma

ConditionGastric or Esophagogastric Junction Adenocarcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorRuijin Hospital

About this trial

In this study, the investigators will use Tislelizumab combined with LM-302 and S-1 versus Tislelizumab combined with SOX to treat Claudin 18.2-positive locally advanced gastric or gastroesophageal junction adenocarcinoma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients voluntarily participate in this study and sign the informed consent form;

Age ≥ 18 years;

Histopathologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma;

HER2 negative;

Disqualifiers

Known HER2-positive gastric cancer；

Gastroesophageal junction (EGJ) cancer involving the proximal stomach with the tumor center located ≤2 cm from the EGJ；

Peritoneal metastasis, positive peritoneal cytology (CY1P0), or retroperitoneal lymph node metastasis (No. 16a2/b1) or other distant metastases;

Presence of unresectable factors, including unresectability due to tumor characteristics, surgical contraindications, or patient refusal of surgery;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Tislelizumab, LM-302 and S-1

    Drug

    Tislelizumab 200mg and LM-302 2.0mg/kg intravenous (IV) infusion on day 1 plus oral S-1: BSA\<1.25 m2, 40mg twice/day; BSA1.25-1.5m2, 50mg twice/day; BSA≥1.5 m2, 60mg twice/day, po, d1-14, q3w.

  • Tislelizumab combined with oxaliplatin and S-1

    Drug

    Tislelizumab 200mg and oxaliplatin 130 mg/m2 intravenous (IV) infusion on day 1 plus oral S-1: BSA\<1.25 m2, 40mg twice/day; BSA1.25-1.5m2, 50mg twice/day; BSA≥1.5 m2, 60mg twice/day, po, d1-14, q3w.

Treatment groups

88 Participants
are divided into 2 treatment groups
Group A: Tislelizumab Combined With LM-302 and S-1Experimental treatment 1 intervention
Group B: Tislelizumab Combined With SOXActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Pathological complete response (pCR) rate

pCR is defined as the absence of residual tumor based on evaluation of the resected stomach and lymph node specimen according to Becker remission criteria

Time frame
up to 24 months

Secondary outcomes

1

treatment related adverse events

Time frame
up to 24 months
2

Major Pathological Response (MPR) rate

Defined as tumor specimens resected after neoadjuvant therapy with residual tumor cells ≤10%

Time frame
up to 24 months
3

R0 resection rate

R0 resection rate was defined as the proportion of patients with complete resection of the tumor and negative margins, i.e. no residual tumors

Time frame
up to 24 months
4

Event-free survival (EFS)

Event-free survival (EFS) is defined as the time from treatment initiation until the occurrence of any predefined event, including disease progression preventing planned surgery, local or distant recurrence, or death from any cause

Time frame
up to 36 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ruijin Hospital

Lead sponsor

Source ClinicalTrials.gov
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