Health TrialsbyHealthPanel

Capeox Regimen Combined With Sintilimab and Bevacizumab for Gastric Cancer

ConditionStomach Neoplasm
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorWest China Hospital

About this trial

The median survival time of first-line chemotherapy for advanced gastric cancer is about one year, and the treatment is still facing the bottleneck. This is a one-arm, open and prospective phase II clinical study. Recruit patients who have been diagnosed with advanced or metastatic adenocarcinoma of the stomach and gastroesophageal junction and have not received systematic treatment.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histological or cytological diagnosis confirmed adenocarcinoma of stomach and gastroesophageal junction (including signet ring cell carcinoma, mucinous adenocarcinoma, hepatoid adenocarcinoma)

Imaging and surgical evaluation of unresectable recurrent or metastatic patients

The expected survival time was more than 3 months

The age is between 18 and 70 years old, both male and female

Disqualifiers

Female subjects of childbearing age were required to conduct a serum pregnancy test within 3 days before the start of the study, and the results were negative, and they were willing to use a medically recognized high-efficiency contraceptive method (such as intrauterine device, contraceptive or condom) during the study period and within 3 months after the last administration of the study drug;For male subjects whose partners are women of childbearing age, they should be sterilized by surgery or agree to use effective contraceptive methods during the study and within 3 months after the last study administration

With my consent and signed the letter of understanding, I am willing and able to follow the planned visit, research treatment, laboratory examination and other test procedures

HER2 + (or HER2 +) is known to be positive

Gastric cancer known as squamous cell carcinoma, undifferentiated or other tissue types, or adenocarcinoma mixed with other tissue types

Trial design

Design model

Single group

Treatments tested in this trial

  • Capeox regimen combined with Sintilimab and Bevacizumab

    Combination product

    Stage Ib：Oxaliplatin +Capecitabine Tablets +Sintilimab +Bevacizumab Stage II：Bevacizumab (the dose determined in phase Ib clinical study)，the dosage of other drugs was the same as before

Treatment groups

57 Participants
are divided into 1 treatment group
Group A: Capeox regimen combined with Sintilimab and BevacizumabExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

the appropriate dose of Bevacizumab

According to the incidence of dose-limited toxic dose -limiting toxicity (DLT) after 2 and 4 cycles of Ib phase treatment, the appropriate dose of Bevacizumab combination was determined.

Time frame
1.5-3months
2

the objective Response Rate (ORR) of the experimental group.

The main purpose of phase II is the objective Response Rate (ORR) of the experimental group.

Time frame
2years

Secondary outcomes

1

progression-free survival（PFS）

Refers to the time between the patient's admission to the treatment and the disease progression

Time frame
1-2years
2

overall survival (OS)

Refers to the time from admission to treatment to death of patients

Time frame
1-3years
3

disease control rate (DCR)

Refers to the proportion of people who receive this program in the whole patient population and achieve complete response ,partial response or stable disease and last for a period of time

Time frame
1-3years

Other outcomes

Sponsors and contacts

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

West China Hospital

Lead sponsor

Source ClinicalTrials.gov
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