Perioperative Treatment of Hepatoid Adenocarcinoma of Stomach

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorPeking University Cancer Hospital & Institute

About this trial

The goal of this clinical trial is to learn if treatment modality including Disitamab Vedotin (RC48), Oxaliplatin,Tegafur,Gimeracil and Oteracil Porassium Capsules (SOX)and Sindillimab works to treat locally advanced hepatoid adenocarcinoma of stomach. It will also learn about the safety of this modality. The main aim it aims to achieve are:

* To evaluate the perioperative efficacy of RC48 combined with sindillizumab and SOX in the treatment of locally advanced HER2-expressing hepatoid adenocarcinoma of stomach * To evaluate the safety and long-term benefits of RC48 combined with sindillizumab and SOX regimens in perioperative treatment of locally advanced HER2-expressing hepatoid adenocarcinoma of stomach

Participants will:

* Preoperative treatment with RC48, SOX and sindillizumab for 4 cycles * Radical surgery after 4-6 weeks of the preoperative treatment * Adjuvant treatment with RC48, Tegafur,Gimeracil and Oteracil Porassium Capsules and sindillizumab for 4 cycles

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

The histological type of gastric hepatoid adenocarcinoma was confirmed by pathological biopsy;

HER2 expression (Immunohistochemistry: 1+,2+,3+);

Patients with clinical stage II-III;

Those who are expected to complete R0 excision;

Disqualifiers

Combined with other malignant tumors (excluding thyroid papillary carcinoma, facial basal cell carcinoma and other low-grade malignant tumors); -Patients with obstruction, bleeding, etc. who need surgical intervention after evaluation by clinicians;

dMMR/MSIH status;

Received other anti-tumor therapy before enrollment.

Trial design

Design model

Single group

Treatments tested in this trial

  • Perioperative treatment

    Drug

    RC48+SOX+Sindilizumab

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: perioperative treatment for hepatoid adenocarcinoma of stomachExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

pathological complete response rate

The proportion of subjects with node-negative lymph nodes and without residual viable tumor cells in the total number of subjects

Time frame
within 10 days after surgery

Secondary outcomes

1

major pathological response rate

The proportion of subjects with surviving tumor cells ≤10% in total subjects;

Time frame
within 10 days after surgery
2

Objective response rate

Proportion of patients who achieved pre-defined tumor volume reduction , including patients with complete response (CR) and partial response (PR).

Time frame
From enrollment to surgery, assessed up to 3 months
3

Event-free survival

From the start of treatment to the first occurrence of any of the following events: disease progression without surgical treatment, local or distant recurrence, death from any cause

Time frame
From date of enrollment until the date of first documented progression, recurrence or date of death from any cause, whichever came first, assessed up to 3 years
4

Disease free survival

It usually starts from the time when the patient receives treatment (such as surgery), and ends at the time when the disease recurs (such as tumor recurrence, metastasis) or when the patient dies for any reason

Time frame
From date of surgery until the date of first documented recurrence or date of death from any cause, whichever came first, assessed up to 3 years

Other outcomes

Sponsors and contacts

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