Not Yet RecruitingPhase 2

Phase II Study of QL1706 Combined With Paclitaxel and Bevacizumab for Second-Line Immune Rechallenge in Gastric Cancer

66 participantsStarted 2025-07-25

Plain-language summary

The study aims to evaluate the efficacy and safety of the QL1706 combination with paclitaxel and bevacizumab in patients with gastric adenocarcinoma and gastroesophageal junction adenocarcinoma who have failed first-line standard therapy.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. Signed written informed consent and voluntarily enrolled in the study.
✓. Aged 18-75 years, regardless of gender.
✓. Histologically or cytologically confirmed unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.
✓. Documented failure after ≥3 cycles of prior first-line PD-(L)1 inhibitor combined with fluorouracil-based or platinum-based chemotherapy.
✓. HER2-negative status (IHC 0/1+ or IHC 2+/FISH-negative).
✓. ECOG Performance Status 0-1.
✓. ≥1 measurable lesion per RECIST v1.1. Previously irradiated lesions cannot be target lesions unless: the irradiated lesion is the sole measurable lesion and documented progression in the irradiated lesion by imaging
✓. Life expectancy ≥3 months.

Exclusion criteria

✕. Histopathological or cytological examination confirms the presence of other pathological components, such as squamous cell carcinoma, undifferentiated carcinoma, neuroendocrine carcinoma, etc.
✕. Previous systemic treatment targeting VEGF or the anti-VEGFR signaling pathway.
✕. Previous treatment with PD-1/CTLA-4 dual immunotherapy.
✕. Previous systemic or local treatment with paclitaxel-based drugs.
✕. Received the last anti-tumor therapy within 5 half-lives (whichever is shorter) prior to the first dose, including chemotherapy, immunotherapy, targeted therapy (within 2 weeks prior to the first dose for small molecule targeted therapy), biological therapy, etc.; Palliative local therapy for non-target lesions within 2 weeks prior to the first dose; Received systemic non-specific immunomodulatory therapy (e.g., interleukin, interferon, thymosin) within 2 weeks prior to the first dose.
✕. History of Grade 3 or higher irAEs (excluding endocrine system-related irAEs) caused by PD-1/PD-L1 inhibitors.
✕. Permanent discontinuation of previous treatment due to irAEs.
✕. Has not adequately recovered (i.e., ≤ Grade 1 or returned to baseline, excluding fatigue or alopecia) from toxicities and/or complications caused by any prior intervention prior to starting treatment.

What they're measuring

PFS

Timeframe: up to 7 months

Dose-limiting toxicity

Timeframe: Within Cycle 1 (21 days)

Trial details

NCT IDNCT07045805

SponsorThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-07-31

Contact for this trial

Jia wei

0086-025-83304616 jiawei99@nju.edu.cn

View on ClinicalTrials.gov More Gastric Cancer (GC) trials