Health TrialsbyHealthPanel

Sintilimab Combined With Chemotherapy as Adjuvant Treatment for Phase III GC and GEJ

ConditionsGastric AdenocarcinomaEsophagogastric Junction Adenocarcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences

About this trial

This study is a prospective, single-arm, phase II clinical study. Screening patients with stage III GC/GEJ adenocarcinoma after D2 or broader radical resection. After enrolling in the study, the subjects receive Sintilimab combined with oxaliplatin+Tegafur, Gimeracil and Oteracil Potassium Capsules (SOX) or oxaliplatin+Capecitabine (XELOX) , in which the combined chemotherapy is up to 8 cycles, and the total course of treatment was 16 cycles. The following-up of subjects includes adverse events、disease status、living conditions and the quality of life.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18.

Patients with histopathological confirmed gastric/GEJ adenocarcinoma.

The pTNM is confirmed between IIIA-IIIC and the PD-L1 CPS>=1.

Patients treated with D2 surgery.

Disqualifiers

Patients who had received neoadjuvent treatments before surgery.

Patients who have discovered tumor relapse or metastasis before adjuvent treatment.

Patients who have other malignant tumors.

Patients who could not swallow the tablets and capsules.

Trial design

Design model

Single group

Treatments tested in this trial

  • Sintilimab plus Chemotherapy

    Biological/Vaccine

    chemotherapy includes SOX and XELOX

Treatment groups

70 Participants
are divided into 1 treatment group
Group A: Sintilimab + SOX/XELOXExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

3-year disease free survival(DFS) rate

The disease free survival rate of 3 years after receiving the first dose of treatment

Time frame
From the time of first dose of adjuvant treatment to the 3 years of the same day

Secondary outcomes

1

DFS

disease free survival

Time frame
From the time of first dose of adjuvant treatment to the time when the subjects have confirmed disease progress
2

overall survival (OS)

overall survival

Time frame
From the time of first dose of adjuvant treatment to the time when the subjects have died for all causes
3

safety

treatment safety and adverse events

Time frame
collect all adverse events since the last medication up to 30 days

Other outcomes

Sponsors and contacts

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

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Lead sponsor

Source ClinicalTrials.gov
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