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Adebrelimab Plus Apatinib Combined With SOX Regimen as Conversion Therapy for Gastric Cancer

ConditionsAdebrelimabAdenocarcinoma of GE JunctionAdenocarcinoma of Stomach
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBeijing Friendship Hospital

About this trial

This is a prospective, single-center, single-arm, open phase II clinical study. Forty-nine participants with pathologically or cytologically confirmed gastric cancer or gastroesophageal junction cancer are scheduled to be enrolled in this study. All participants will be treated with 2 to 8 cycles of adebrelimab, apatinib, oxaliplatin, and tigio before surgery. Participants will evaluate the treatment effect after every 2 cycles of medication. By the investigator assessment as an operable subject, apatinib was discontinued for one cycle. The adjuvant treatment will be determined by the investigators based on the participants' postoperative pathology results. Participants requiring adjuvant therapy, with a postoperative interval of at least 4 weeks, but not more than 10 weeks. When the resection standard isn't met for 8 cycles of treatment, the treatment is switched to a maintenance phase, which the subject treatment regimen is determined by the investigator. During the treatment period, participants will receive the study drugs on Day 1 of each 21-day cycle until evidence of disease progression or unacceptable toxicity.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-75 years at the time of enrollment, with an estimated life expectancy of ≥ 3 months.

Histologically or cytologically confirmed gastric cancer or gastroesophageal junction cancer, predominantly adenocarcinoma.

Unresectable locally advanced gastric or gastroesophageal junction adenocarcinoma (Stage III or IV), as determined by the investigator based on CT, MRI, and/or PET-CT.

Disease with conversion (translational) therapeutic potential, as assessed by the investigator.

Disqualifiers

HER2-positive gastric or gastroesophageal junction adenocarcinoma.

Conditions that may significantly affect oral drug absorption, including inability to swallow, persistent nausea or vomiting, chronic diarrhea, or intestinal obstruction.

Known hypersensitivity or allergy to adebrelimab, apatinib, oxaliplatin, S-1 (tegafur/gimeracil/oteracil), or any of their excipients.

History of severe allergic reactions to monoclonal antibodies.

Trial design

Design model

Single group

Treatments tested in this trial

  • Adebrelimab

    Drug

    1200 mg, iv.gtt, single infusion, 21 days as a cycle, Day 1

  • Apatinib

    Drug

    250mg, p.o, qd, 21 days as a cycle

  • SOX Chemotherapy

    Drug

    Oxaliplatin: 130mg/m2, iv.gtt, single infusion, 21 days as a cycle, Day 1. Tigio: 40mg (body surface area(BSA)\<1.25m2), 50mg (BSA≥1.25m2, and BAS\<1.5m2), 60mg (BSA ≥1.5m2), p.o, bid, 21 days as a cycle, Day 1-14.

Treatment groups

49 Participants
are divided into 1 treatment group
Group A: Adebrelimab + Apatinib + SOXExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

R0 resection rate

Proportion of participants who achieve R0 resection, defined as microscopically margin-negative resection confirmed by postoperative pathological examination.

Time frame
At the time of definitive surgery following completion of neoadjuvant treatment (within 6 months from enrollment)
2

Adverse Events (AE)

Incidence, nature, and severity of treatment-emergent adverse events (AEs), graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0.

Time frame
From treatment initiation to 30 days after the last dose of study treatment (up to approximately 6 months).

Secondary outcomes

1

Objective response rate (ORR)

ORR is defined as the percentage of participants who achieve a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR), as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

Time frame
up to 1year
2

Overall survival (OS)

Time from day of study to death due to any cause.

Time frame
Up to 3 years
3

Disease Free Survival (PFS)

Time from enrollment to disease progression or death from any cause, whichever occurs first.

Time frame
Up to 2 years

Other outcomes

Sponsors and contacts

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

Beijing Friendship Hospital

Lead sponsor

Source ClinicalTrials.gov
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