A Multicenter Randomized Controlled Phase II Trial of Iparomlimab and Tuvonralimab (QL1706) Combined With SOX Chemotherapy Versus Chemotherapy Alone in the Treatment of Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShandong Provincial Hospital

About this trial

To explore the efficacy of Iparomlimab and Tuvonralimab (QL1706) in combination with SOX chemotherapy versus chemotherapy alone for the neoadjuvant treatment of locally-progressed gastric/gastroesophageal union adenocarcinomas by evaluating the complete pathologic remission rate (pCR).

Eligibility criteria

Qualifiers

Voluntary participation in the study and signing of informed consent;

Age ≥18 years and ≤75 years;

Pathologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma;

Clinical staging of T3N+ or T4a any N, M0 (according to AJCC 8th edition staging), with potential radical resection confirmed by CT or MRI;

Disqualifiers

Known HER2 positivity;

Known peritoneal metastases or positive peritoneal cytology (CY1P0) or T4b (according to AJCC 8th edition);

Presence of unresectable factors including unresectable tumors, contraindications to surgery and refusal of surgery;

The presence of a pre-existing or concurrent malignancy, with the exception of cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, and carcinoma in situ of the breast

Trial design

Treatments tested in this trial

  • Neoadjuvant Therapy(QL1706+SOX Chemotherapy)
  • Neoadjuvant Therapy(SOX Chemotherapy)
  • Radical surgery (D2)
  • Drug: Adjuvant therapy(QL1706+SOX chemotherapy)
  • Drug: Adjuvant therapy(SOX chemotherapy)

Treatment groups

96 Participants
are divided into 2 treatment groups

Sponsors and collaborators