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Adebrelimab Combined With Induction Chemotherapy or SHR-8068 for Mismatch Repair-Deficient/Microsatellite Instability-High (dMMR/MSI-H) Locally Advanced Gastric/Gastroesophageal Junction Adenocarcinoma：A Randomized, Non-comparative Phase 2 Study

ConditionsGastric AdenocarcinomaGastroesophageal AdenocarcinomaMismatch Repair Deficient or MSI-High Solid TumorsImmunotherapy
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai Zhongshan Hospital

About this trial

This is a randomized, non-comparative, open-label, two-arm phase II clinical trial designed to evaluate the efficacy and safety of neoadjuvant therapy with adebrelimab plus induction chemotherapy versus adebrelimab plus SHR-8086 in patients with dMMR/MSI-H gastric or gastroesophageal junction adenocarcinoma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female, age ≥ 18 years

Pathologically confirmed gastric or gastro-oesophageal-junction adenocarcinoma (Siewert II and III only)

dMMR confirmed by IHC or MSI-H confirmed by PCR

Investigator-assessed potentially curative resection feasible before study entry

Disqualifiers

Tumour histology squamous-cell, neuro-endocrine, or other non-adenocarcinoma types

Unresectable disease (tumour-related or surgical contraindication) or subject refuses surgery

Tumour requiring transthoracic surgical approach

CNS metastases and/or carcinomatous meningitis

Trial design

Design model

Parallel

Treatments tested in this trial

  • Adebrelimab

    Drug

    Participants in both arms will receive neoadjuvant adebrelimab 1200mg intravenously on day 1 of a 21-day cycle for four cycles.

  • XELOX

    Drug

    Participants assigned to arm 1 will receive neoadjuvant XELOX (capecitabine 1000 mg/m² orally twice daily on days 1-14 plus oxaliplatin 130 mg/m² intravenously on day 1) for one cycle.

  • SHR-8068

    Drug

    Participants assigned to arm 2 will receive SHR-8068 280 mg administered intravenously on day 1 for one cycle.

  • D2 radical gastrectomy

    Procedure/Surgery

    Curative-intent D2 radical gastrectomy is scheduled 4-6 weeks after completion of the fourth cycle.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Arm 1Experimental treatment 3 interventions
Group B: Arm 2Experimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Pathological complete response (pCR) rate

The proportion of participants in whom no viable tumor cells remain in the primary tumor bed and regional lymph nodes (ypT0N0).

Time frame
From randomization to the date of surgery, an average of 14 weeks.

Secondary outcomes

1

Major pathological response (MPR) rate

The proportion of participants in whom residual viable tumor cells constitute \<10 % of the primary tumor bed in the resected surgical specimen.

Time frame
From randomization to the date of surgery, an average of 14 weeks.
2

ypN stage

Lymph-node status after neoadjuvant therapy (ypN stage) will be assessed according to the American Joint Committee on Cancer (AJCC) 8th edition staging system.

Time frame
From randomization to the date of surgery, an average of 14 weeks.
3

R0 resection rate

The proportion of patients who undergo surgery with microscopically negative resection margins.

Time frame
From randomization to the date of surgery, an average of 14 weeks.
4

Event-free survival (EFS)

Time frame
The time from randomization to documented disease progression, disease recurrence, or death from any cause, whichever occurs first, assessed up to 5 years.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

Shanghai Zhongshan Hospital

Lead sponsor

Source ClinicalTrials.gov

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