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

NCT06829797 | Recruiting Phase 2

• 1 other identifier: NO.2024-1046
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Locally Advanced Gastric/Gastroesophageal Junction Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Pathological complete response rate (pCR)

  Pathological complete response was defined as pT0N0M0

  From date of neoadjuvant therapy until the date of postoperative pathological assessment, assessed up to 14-16 weeks.

Secondary Outcomes (9)

• Major pathological response rate (MPR)

  From date of neoadjuvant therapy until the date of postoperative pathological assessment, assessed up to 14-16 weeks.

• R0 resection rate

  From date of neoadjuvant therapy until the date of postoperative pathological assessment, assessed up to 14-16 weeks.

• Event-free survival (EFS)

  From date of neoadjuvant therapy until the date of the first occurrence of the above events, assessed up to 60 months.

• Overall survival (OS)

  From the date of diagnosis to the date of death, assessed up to 60 months.

• Disease-free survival (DFS)

  From date of neoadjuvant therapy until the date of the disease recurrence or death due to disease progression, assessed up to 60 months.

Study Arms (2)

QL1706+SOX group

EXPERIMENTAL

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

SOX group

ACTIVE COMPARATOR

Drug: Neoadjuvant Therapy(SOX Chemotherapy); Procedure: Radical surgery (D2); Drug: Drug: Adjuvant therapy(SOX chemotherapy)

Interventions

Neoadjuvant Therapy(QL1706+SOX Chemotherapy) DRUG

Preoperative QL1706 combined with SOX regimen (4 cycles) → Radical surgery (D2) → Postoperative QL1706 combined with SOX regimen (4 cycles). QL1706 (50mg/2mL) , at a dose of 5mg/kg, the desired volume of drug is withdrawn and slowly infused into an IV bag of 0.9% NaCl, prepared as a diluent with a final concentration of 1-10mg/mL, mixed, and infused intravenously, Q3W, administered on the first day of each cycle.

QL1706+SOX group

Neoadjuvant Therapy(SOX Chemotherapy) DRUG

Preoperative SOX regimen (4 cycles) → radical surgery (D2) → postoperative SOX regimen (4 cycles).

SOX group

Radical surgery (D2) PROCEDURE

Surgical treatment is completed within 3-5 weeks after the end of neoadjuvant therapy.

QL1706+SOX group; SOX group

Drug: Adjuvant therapy(QL1706+SOX chemotherapy) DRUG

Postoperative adjuvant therapy is 4 cycles of QL1706+SOX chemotherapy.

QL1706+SOX group

Drug: Adjuvant therapy(SOX chemotherapy) DRUG

Postoperative adjuvant therapy is 4 cycles of SOX chemotherapy.

SOX group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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 ≥ 12 months;
• Normal major organ function.

You may not qualify if:

• 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 currently receiving thrombolytic or anticoagulant therapy (prophylactic use of low-dose aspirin and low-molecular-weight heparin is allowed);
• Clinically significant bleeding symptoms or significant bleeding tendency such as gastrointestinal bleeding, gastric ulcer bleeding, and vasculitis within 3 months prior to randomization into groups. Patients with positive fecal occult blood at baseline may be retested, and if the retest remains positive, gastroscopy will be required (except for patients who have had a gastroscopy within 3 months prior to enrollment to rule out this condition);
• Arterial/venous thrombotic events such as cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage, and cerebral infarction), deep vein thrombosis, and pulmonary embolism within 6 months prior to randomization to group;
• A known hereditary or acquired predisposition to bleeding and thrombosis (e.g., hemophilia, coagulation disorders, and thrombocytopenia);
• The presence of active ulcers, unhealed wounds or fractures
• Urinalysis showing urinary protein ≥++, confirmed by 24-hour urine protein quantification \>1.0 g;
• Active infections requiring antimicrobial therapy (e.g., antibacterial, antiviral, and antifungal medications);
• Active hepatitis (Hepatitis B reference: HBsAg positive and HBV DNA ≥ 500 IU/mL; Hepatitis C reference: HCV antibody positive and HCV viral copy number \> upper limit of normal (ULN));
• Congenital or acquired immunodeficiency (e.g., HIV-infected patients);
• Planned or previous organ or allogeneic bone marrow transplant;

Sponsors & Collaborators

• Shandong Provincial Hospital: lead

Study Sites (1)

Shandong Provincial Hospital

Jinan, Shandong, 250021, China

RECRUITING

Central Study Contacts

Liang Shang

CONTACT

+8615866602157; docshang@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 6, 2025
• First Posted: February 17, 2025
• Study Start: March 11, 2025
• Primary Completion (Estimated): February 29, 2028
• Study Completion (Estimated): February 29, 2028
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

CN (1)