A Multicenter Randomized Controlled Phase II Trial of Iparomlimab and Tuvonralimab (QL1706) Combiā¦ (NCT06829797) | Clinical Trial Compass
RecruitingPhase 2
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
China96 participantsStarted 2025-03-11
Plain-language summary
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).
Who can participate
Age range18 Years ā 75 Years
SexALL
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Inclusion Criteria:
* Voluntary participation in the study and signing of informed consent;
* Age ā„18 years and ā¤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;
* Have not received any anti-tumor therapy (e.g., surgery, radiotherapy, chemotherapy, targeted therapy and immunotherapy);
* Planned to undergo surgery after completion of neoadjuvant therapy;
* Be able to swallow pills normally;
* ECOG-PS score 0-1;
* Expected survival ā„ 12 months;
* Normal major organ function.
Exclusion Criteria:
* 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
* History of gastrointestinal perforation, history of abdominal abscess or recent (within 3 months) occurrence of intestinal obstruction, or concomitant intestinal obstruction as indicated by imaging or clinical signs;
* Patients with abnormal coagulation (International Normalized Ratio (INR) \>2.0 or Prothrombin Time (PT) \>16s), a bleeding tendency or cā¦
What they're measuring
1
Pathological complete response rate (pCR)
Timeframe: From date of neoadjuvant therapy until the date of postoperative pathological assessment, assessed up to 14-16 weeks.