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Efficacy and Safety of Anti-PD-1, Thymalfasin, and SOX in Neoadjuvant Treatment of cStage III Gastric/Gastroesophageal Junction Adenocarcinoma

ConditionsGastric CancerEsophagogastric Junction Adenocarcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorZekuan Xu

About this trial

This Phase II clinical study is a prospective, open-label, single-arm trial designed to evaluate the efficacy and safety of combining anti-PD-1 therapy (Serplulimab) with thymalfasin and the SOX chemotherapy regimen as a neoadjuvant treatment for patients with clinical stage III gastric or gastroesophageal junction(GEJ) adenocarcinoma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • Serplulimab

    Drug

    300 mg, i.v., D1, Q3W

  • thymalfasin

    Drug

    4.8mg,sc,biw

  • Oxaliplatin

    Drug

    130 mg/m2, i.v., D1, Q3W

  • Tegafur

    Drug

    oral administration: body surface area \< 1.25, 40 mg each time; body surface area ≥ 1.25 to \< 1.5, 50 mg each time; body surface area ≥ 1.5, 60 mg each time, twice daily for each treatment cycle at D1-D14

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Serplulimab Combined with Thymalfasin and SOXExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

pathological Complete Response (pCR)

pCR was defined as no residual tumor cells on the histologic examination of surgical specimens.

Time frame
from preoperative to 10 days postoperative

Secondary outcomes

1

Major Pathological Response (MPR)

For patients with surgically resectable gastric cancer after neoadjuvant therapy, the proportion of patients with less than 10% residual tumor cells in the primary site.

Time frame
from preoperative to 10 days postoperative
2

Tumor Regression Grade (TRG)

It is intended to grade the pathological response of tumor after neoadjuvant therapy and generally divide the grade mainly according to the proportion of fibrosis and residual tumor in the tumor. In this study, Becker criteria are used to grade TGR as follows: TRG1a (no residual tumor), equivalent to pCR; TRG1b (\< 10% residual tumor); TRG2 (10% to 50% residual tumor); and TRG3 (\> 50% residual tumor).

Time frame
from preoperative to 10 days postoperative
3

Clinical downstaging rate (T and/or N downstaging)

ypT0 ratio, ypN0 ratio, and preoperative imaging clinical stage will be counted, respectively, to compare with baseline imaging clinical stage downstaging ratio

Time frame
before surgery
4

Objective Response Rate (ORR)

It refers to the proportion of patients whose tumor shrinks to a certain extent and remains for a certain period of time, including CR (Complete Response) and PR (Partial Response) cases. Objective tumor response will be assessed using Response Evaluation Criteria in Solid Tumors (RECIST 1.1 criteria).

Time frame
before surgery

Other outcomes

Sponsors and contacts

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

Zekuan Xu

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Sponsor institution

Source ClinicalTrials.gov
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