Phase II Trial of Iparomlimab/Tuvonralimab (QL1706) + XELOX in HER2-Negative, Low PD-L1 G/GEJ Adenocarcinoma (SEARCH)

May 2, 2026 updated by: Lian Liu, MD, PHD, Qilu Hospital of Shandong University

Safety and Efficacy of Iparomlimab and Tuvonralimab (QL1706) Combined With Chemotherapy for the Treatment of HER2-Negative, Low PD-L1 Expressing, Unresectable or Metastatic Gastric/Gastroesophageal Junction Adenocarcinoma: A Phase II Single-Arm Trial

This is single - arm study to explore the safety and efficacy of iparomlimab and tuvonralimab (QL1706) combined with chemotherapy for treating her2-negative, low PD-L1 expressing, unresectable or metastatic gastric/gastroesophageal junction adenocarcinoma

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

77

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Lian Liu, MD, PHD
  • Phone Number: 0531-82169851
  • Email: tounao@126.com

Study Contact Backup

  • Name: Song Li, MD, PHD
  • Phone Number: 0531-82169851

Study Locations

  • China
      • Jining, China
        • Recruiting
        • Jining First People's Hospital
        • Contact:
          • Jie Li
    • Henan
      • Zhengzhou, Henan, China, 450052
        • Recruiting
        • The First Affiliated Hospital of Zhengzhou University
        • Contact:
        • Contact:
    • Shandong
      • Binzhou, Shandong, China
        • Recruiting
        • Binzhou Medical University Hospital
        • Contact:
          • Feng Wang
      • Dezhou, Shandong, China
        • Recruiting
        • Dezhou People's Hospital
        • Contact:
          • Tao Li
      • Dongying, Shandong, China
        • Recruiting
        • Shengli Oilfield Central Hospital
        • Contact:
      • Jinan, Shandong, China, 250012
        • Recruiting
        • Qilu Hospital of Shandong University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Lian Liu, MD, PHD
      • Jinan, Shandong, China
        • Recruiting
        • Jinan Central Hospital
        • Contact:
          • Meili Sun
      • Jinan, Shandong, China, 250012
        • Recruiting
        • Shandong Provincial Hospital Affiliated to Shandong First Medical University
        • Contact:
        • Principal Investigator:
          • Lei Cong, MD
      • Jinan, Shandong, China, 250012
        • Recruiting
        • Shandong Provincial Third Hospital
        • Contact:
      • Jinan, Shandong, China
        • Recruiting
        • Jinan Third People's Hospital
        • Contact:
          • Zupeng Luan
      • Jinan, Shandong, China
        • Recruiting
        • Shandong Qianfoshan Hospital
        • Contact:
          • Jing Liang
      • Jining, Shandong, China
        • Recruiting
        • Affiliated Hospital of Jining Medical College
        • Contact:
          • Junye Wang, MD
      • Liaocheng, Shandong, China
        • Recruiting
        • Liaocheng People's Hospital
        • Contact:
          • Baozhong Wang
      • Linyi, Shandong, China
        • Recruiting
        • Linyi Cancer Hospital
        • Contact:
          • Zhen Li
      • Linyi, Shandong, China
        • Recruiting
        • Linyi people's hospital
        • Contact:
          • Jinling Zhang
      • Qingdao, Shandong, China
        • Recruiting
        • The Affiliated Hospital Of Qingdao University
        • Contact:
          • Ziming Liu
      • Qingdao, Shandong, China
        • Recruiting
        • Qingdao Municipal Hospital
        • Contact:
          • Lu Yue
      • Qingdao, Shandong, China, 250063
        • Recruiting
        • Qilu Hospital of Shandong University(Qingdao)
        • Contact:
      • Tai’an, Shandong, China
        • Recruiting
        • Taian City Central Hospital
        • Contact:
          • Li Meng, MD
      • Tai’an, Shandong, China
        • Recruiting
        • The Second Affiliated Hospital of Shandong First Medical University
        • Contact:
      • Tengzhou, Shandong, China, 277599
        • Recruiting
        • Tengzhou Central People's Hospital
        • Contact:
      • Weifang, Shandong, China
        • Recruiting
        • Weifang Hospital of Traditional Chinese Medicine
        • Contact:
          • Zhonghai Du
      • Weihai, Shandong, China
        • Recruiting
        • Weihai Central Hospital
        • Contact:
          • Ming Wang
      • Yantai, Shandong, China
        • Recruiting
        • Yantai Yuhuangding Hospital
        • Contact:
          • Ping Sun
      • Yantai, Shandong, China
        • Recruiting
        • Yantaishan Hospital
        • Contact:
      • Zibo, Shandong, China
        • Recruiting
        • Zibo Central Hospital
        • Contact:
      • Zibo, Shandong, China
        • Recruiting
        • Zibo First People's Hospital
        • Contact:
          • Fei Ding

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Aged 18-75 years, gender is not limited;
  2. Pathologically confirmed locally advanced gastric or gastroesophageal junction adenocarcinoma that is inoperable or has distant metastasis;
  3. HER2-negative by immunohistochemistry (IHC);
  4. low PD-L1 expression status (CPS < 5);
  5. Has at least 1 measurable lesion as determined by RECIST 1.1;
  6. No systematic treatment in the past, or the patient has received neoadjuvant/adjuvant chemotherapy, but the disease progresses or relapses more than 6 months after the end of treatment;
  7. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
  8. Adequate organ function;
  9. The life expectancy is at least 3 months;
  10. Willing to join the study and signed an informed consent form (ICF) with good compliance and cooperation in follow-up.

Exclusion Criteria:

  1. Allergic to any trial drug and its excipients, or serious allergy history, or contraindication of the trial drug;
  2. Cardiovascular and cerebrovascular events that are not well controlled;
  3. Has received systematic treatment with Chinese patent medicine or immunomodulatory drugs (including thymosin, interferon, interleukin, except for local use for ascites control) before the first administration within 2 weeks;
  4. Have a history of interstitial lung disease, non-infectious pneumonia, pulmonary fibrosis, acute lung disease, or systemic disease with poor control (including but not limited to diabetes, hypertension, etc.);
  5. Have a history of active immune deficiency or autoimmune diseases, including HIV positive test, or have other acquired or congenital immune deficiency diseases, or have a history of organ transplantation or autoimmune diseases;
  6. Severe chronic or active infection requires systemic antibacterial, antifungal or antiviral treatment, including tuberculosis infection.Have a history of active tuberculosis infection ≥ 1 year before recruitment should also be excluded, unless proved has been completed appropriate treatment;
  7. Brain metastasis or leptomeningeal metastasis;
  8. Clinically significant pleural effusion, pericardial effusion or ascites should be drained for many times within 2 weeks before the first administration of the trial drug;
  9. Has a second clinically detectable primary malignant tumor at the time of recruitment, or there were other malignant tumors in the past 5 years (except for fully treated skin basal cell carcinoma or cervical carcinoma in situ);
  10. Any major surgery was performed ≤ 28 days before the first trial drug administration;
  11. History of allogeneic stem cell transplantation or organ transplantation;
  12. Duodenal ulcer, ulcerative colitis, intestinal obstruction and other gastrointestinal diseases at present; or other conditions that may cause gastrointestinal bleeding or perforation judged by the researchers; or history of intestinal perforation or fistula, but has not recovered after surgical treatment;
  13. Live vaccine was inoculated within 4 weeks (inclusive) before the first administration of the trial drug, not including seasonal influenza vaccines but intranasal vaccine.
  14. Has other factors that may lead to the forced termination of this trial according to the judgment of the investigator, such as other serious diseases (including psychological and mental diseases) requiring combined treatment, serious laboratory examination abnormalities, and family or social factors, which may affect the safety of the subject, or the collection of data and samples;
  15. Participating in other therapeutic clinical studies or using research instruments within 4 weeks before the first administration;
  16. Others conditions do not meet the inclusion according to the judgment of the investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: QL1706 + XELOX chemotherapy
Iparomlimab and Tuvonralimab+XELOX
Drug: Iparomlimab and Tuvonralimab (QL1706)
5 mg/kg, ivdrip, Day 1, Q3W, until progressive disease or intolerable toxicity.
Drug: Oxallplation
130 mg/m2, ivdrip, Day 1, Q3W, for the first 6 cycles.
Drug: Capectitabine Tablets
1000 mg/m2, po, bid, Days 1-14, Q3W, until progressive disease or intolerable toxicity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
progression-free survival (PFS)
Time Frame: 12 months after the last subject participating in
The time from the starting date of study drug to the date of first documentation of disease progression or death, whichever occurs first (per RECIST 1.1).
12 months after the last subject participating in

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival (OS)
Time Frame: 12 months after the last subject participating in
The time from the starting date of study drug to the date of death due to any cause.
12 months after the last subject participating in
objective response rate (ORR)
Time Frame: 6 months after the last subject participating in
The proportion of subjects with complete response (CR) and partial response (PR) according RESIST1.1 in total subjects.
6 months after the last subject participating in
duration of response (DOR)
Time Frame: 12 months after the last subject participating in
The time from the date for first documented response of complete response (CR) or partial response (PR) to the date of first documented of disease progression or death, whichever occurs first.
12 months after the last subject participating in
disease control rate (DCR)
Time Frame: 12 months after the last subject participating in
The proportion of subjects with complete response (CR) and partial response (PR) and stable disease(SD) in total subjects
12 months after the last subject participating in
Safety (adverse event)
Time Frame: Up to approximately 2 years
The rates of adverse events.
Up to approximately 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qilu Hospital of Shandong University

Investigators

  • Principal Investigator: Lian Liu, MD, PHD, Qilu Hospital of Shandong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 26, 2025

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

October 31, 2027

Study Registration Dates

First Submitted

April 10, 2025

First Submitted That Met QC Criteria

April 16, 2025

First Posted (Actual)

April 17, 2025

Study Record Updates

Last Update Posted (Actual)

May 7, 2026

Last Update Submitted That Met QC Criteria

May 2, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SEARCH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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