Health TrialsbyHealthPanel

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

ConditionLocally Advanced Gastric/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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • 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 QL1706 (50mg/2mL) , at a dose of 5mg/kg, the desired volume of drug is withdrawn and slowly infused into an IV bag of 0.9% NaCl, prepared as a diluent with a final concentration of 1-10mg/mL, mixed, and infused intravenously, Q3W,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.

  • Neoadjuvant Therapy(SOX Chemotherapy)

    Drug

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

  • Radical surgery (D2)

    Procedure/Surgery

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

  • Drug: Adjuvant therapy(QL1706+SOX chemotherapy)

    Drug

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

  • Drug: Adjuvant therapy(SOX chemotherapy)

    Drug

    Postoperative adjuvant therapy is 4 cycles of SOX chemotherapy.

Treatment groups

96 Participants
are divided into 2 treatment groups
Group A: QL1706+SOX groupExperimental treatment 3 interventions
Group B: SOX groupActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

Pathological complete response rate (pCR)

Pathological complete response was defined as pT0N0M0

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

Secondary outcomes

1

Major pathological response rate (MPR)

The percentage of surviving tumor cells in the tumor bed after neoadjuvant therapy was ≤10%.

Time frame
From date of neoadjuvant therapy until the date of postoperative pathological assessment, assessed up to 14-16 weeks.
2

R0 resection rate

The proportion of patients who completed R0 resection in the total enrolled patients.

Time frame
From date of neoadjuvant therapy until the date of postoperative pathological assessment, assessed up to 14-16 weeks.
3

Event-free survival (EFS)

From the beginning of the study to the time of the first occurrence of any of the following events, disease progression beyond surgical treatment, local or distant recurrence, death from any cause, etc.

Time frame
From date of neoadjuvant therapy until the date of the first occurrence of the above events, assessed up to 60 months.
4

Overall survival (OS)

From study inception to patient death from any cause.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shandong Provincial Hospital

Lead sponsor

Source ClinicalTrials.gov
Apply now