First-line Treatment of Gastric or Gastroesophageal Junction Adenocarcinoma With Dual Immunothera… (NCT07400315) | Clinical Trial Compass
Not Yet RecruitingPhase 2
First-line Treatment of Gastric or Gastroesophageal Junction Adenocarcinoma With Dual Immunotherapy Combined With Chemotherapy
64 participantsStarted 2026-03-01
Plain-language summary
A prospective, single-arm, multicenter, Phase II clinical study of Apatolimab Tovolimab (QL1706) in combination with modified FLOT regimen (TFOX) as first-line treatment for HER2-negative advanced gastric or gastroesophageal junction adenocarcinoma
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* 1\. The participant voluntarily agrees to participate in this study, signs the informed consent form, and strictly adheres to the requirements of the study protocol.
* 2\. Age ≥18 years and ≤75 years at enrollment, regardless of gender.
* 3\. Histologically confirmed unresectable locally advanced or metastatic G/GEJ adenocarcinoma, with inclusion criteria specifying HER2- status (HER2+ status defined as IHC3+ or IHC2+ and FISH+).
* 4\. No prior systemic treatment for unresectable locally advanced or metastatic G/GEJ adenocarcinoma; previous neoadjuvant and/or adjuvant therapy is acceptable, but all systemic treatments must have been completed at least 12 months prior to the diagnosis of unresectable or metastatic disease.
* 5\. At least one measurable tumor lesion according to RECIST 1.1 criteria.
* 6\. ECOG PS of 0 or 1.
* 7\. Life expectancy ≥3 months.
* 8\. Fully recovered from any toxicities related to prior treatments prior to enrollment in the study.
* 9\. BMI \>18.
* 10\. Adequate function of major organs
* 11\. Fertile subjects must use appropriate contraception during the study and for 120 days after the end of the study. They must have a negative serum pregnancy test within 7 days prior to enrollment and must not be breastfeeding.
Exclusion Criteria:
* 1\. Any unstable systemic disease: including active infection, uncontrolled hypertension, unstable angina, angina that started within the last 3 months, congestive heart failure (New York Hear…
What they're measuring
1
Median progression-free survival
Timeframe: 1 year
Trial details
NCT IDNCT07400315
SponsorThe First Affiliated Hospital with Nanjing Medical University