Systemic Application of Cadonilimab, LM-302, and S-1 Combined With Intraperitoneal Infusion of Paclitaxel for the Treatment of Claudin 18.2-positive Gastric Cancer With Peritoneal Metastasis

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorRuijin Hospital

About this trial

In this phase 2 study, we combined Cadonilimab, LM-302, and S-1 combined with intraperitoneal infusion of paclitaxel as regimen to treat gastric cancer patients with peritoneal metastasis.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically confirmed gastric adenocarcinoma with her 2 (-), and without the history of resection of primary or metastatic lesion;

Peritoneal metastases from gastric cancer requiring definitive diagnosis by laparoscopy, and without gastric outflow tract obstruction and intestinal obstruction; Written (signed) informed consent;

Claudin 18.2 positive (≥ 25%, and the proportion of positive cells greater than 50% of the cases accounted for not less than 70%);

Age ≥ 18 years at registration;

Disqualifiers

Confirmed of evidence of distant metastasis other than peritoneal metastasis (e.g.liver metastasis, lung metastasis, para-aortic lymph node metastasis, etc.);

During pregnancy, within 28 days of post parturition, or during lactation;

Previously received immunotherapy such as PD-1/PD-L1 and CTLA-4 or targeted therapy such as Claudin 18.2.

Synchronous or metachronous (within 5 years) malignancies.

Trial design

Design model

Single group

Treatments tested in this trial

  • Cadonilimab, LM-302, S-1, paclitaxel

    Drug

    Cadonilimab 10mg/kg, LM-302 2.0mg/kg intravenous (IV) infusion on day 1, paclitaxel 20 mg/m2 intraperitoneal infusion on Days 1 and 8 plus oral S-1 80 mg/m2 for 14 consecutive days every 3 weeks.

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: ExperimentalExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

1-year survival rate

Time frame
up to 24 months

Secondary outcomes

1

treatment related adverse events

Time frame
24 months
2

Objective response rate

Time frame
up to 24 months
3

pCR rate after conversion surgery

Time frame
up to 24 months
4

Duration of Response

Duration of Response

Time frame
up to 24 months

Other outcomes

Sponsors and contacts

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