Colon CancerPhase 2NCT07156682
QL1706 Plus XELOX as Neoadjuvant Therapy for MSS/pMMR Clinical Stage III Colon Cancer
A Phase 2 study testing QL1706 and XELOX in people with Colon Cancer and MSS/pMMR, run by Qilu Hospital of Shandong University at 1 site in China.
Trial summary
This is a single-arm, exploratory study enrolling participants with resectable stage III pMMR/MSS colon cancer. Eligible participants who provide written informed consent will receive four cycles of neoadjuvant treatment with iparomlimab and tuvonralimab (QL1706) plus XELOX regimen administered every three weeks… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colon Cancer, MSS/pMMR, QL1706
- What is being tested?
- QL1706 and XELOX
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteChina
- Study dates
- 25 Sep 2025to 30 Jun 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 75 years.
- Histologically or clinically confirmed initially resectable Stage III colon cancer according to the AJCC 8th edition.
- ECOG performance status of 0 or 1.
- pMMR/MSS status confirmed by a local testing center.
- No planned neoadjuvant radiotherapy.
- Participants must voluntarily participate in the study, sign an informed consent form, and demonstrate good compliance.
- Adequate organ function.
Who cannot join
- Stage IV colon cancer.
- Prior treatment with immune checkpoint inhibitors targeting CTLA-4, PD-1, or PD-L1.
- Current participation in another clinical trial and receiving investigational drugs.
- History of or contraindication to severe allergic reactions to immunotherapy.
- Pregnancy or lactation.
- Active infection requiring treatment.
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- Use of immunosuppressive medications.
- Active cardiovascular disease, including stroke or myocardial infarction within 6 months before enrollment, unstable angina, congestive heart failure, or severe uncontrolled arrhythmia requiring medication that may preclude surgery.
- Patients with acute conditions such as obstruction, hemorrhage, or perforation that require immediate surgery.
- Any other condition deemed by the investigator to render the participant unsuitable for the clinical study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Qilu hospital of Shandong University
Jinan, Shandong, 250012
Jian Wang, Dr., +86 18560088226, wang.jian@sdu.edu.cn
Jing Hao, Deputy Director, MD, PhD
About this study
Official title: A Single-Arm, Exploratory Study of Iparomlimab and Tuvonralimab (QL1706) Plus XELOX as Neoadjuvant Therapy in Patients With Microsatellite Stable (pMMR/MSS) Resectable Stage III Colon Cancer
This is a single-arm, exploratory study enrolling participants with resectable stage III pMMR/MSS colon cancer. Eligible participants who provide written informed consent will receive four cycles of neoadjuvant treatment with iparomlimab and tuvonralimab (QL1706) plus XELOX regimen administered every three weeks (Q3W), followed by radical surgery within two weeks after the last neoadjuvant treatment. After surgery, participants will enter the follow-up phase, or clinicians may decide to administer four additional cycles of adjuvant XELOX chemotherapy based on postoperative pathological findings. The primary endpoint of this study is the pathological complete response (pCR) rate as assessed by investigators. Other endpoints include pathological response (PR), major pathological response (MPR), clinical complete response (cCR), event-free survival (EFS), overall survival (OS), and safety.
- Conditions
- Colon Cancer, MSS/pMMR, QL1706
- Being tested
- QL1706, XELOX
- Keywords
- Iparomlimab and Tuvonralimab, QL1706, Neoadjuvant, MSS/pMMR, Colon Cancer
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QL1706Drug
neoadjuvant administered at a dose of 5 mg/kg, intravenous infusion, every three weeks (Q3W), on day 1 of each cycle, 4 cycles
XELOXDrug
Oxaliplatin 130 mg/m² by intravenous infusion on Day 1; Capecitabine 850-1000 mg/m² orally twice daily (morning and evening) from Day 1 to Day 14; 4 Cycles in total.
| Study group | Role | What they receive |
|---|---|---|
| QL1706 + XELOX | Experimental | Not described Receives: Drug: QL1706; Drug: XELOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological Complete Response (pCR)
No residual viable tumor cells were found in the postoperative pathological assessment.
Measured: Approximately 1 month after surgery.
Secondary outcomes (6)
Major Pathological Response (MPR)
Postoperative pathology shows at least 10% tumor regression.
Measured: Approximately 1 month after surgery.
Pathological Response (PR)
Postoperative pathology shows at least 50% tumor regression.
Measured: Approximately 1 month after surgery.
Clinical Complete Response (cCR)
No evidence of residual tumor is found via imaging, endoscopic examination, and clinical assessment
Measured: Approximately 4 months after last participant enrollment.
Event-Free Survival (EFS)
The time from initial treatment to the occurrence of any event, including disease progression, treatment discontinuation for any reason, or death.
Measured: Approximately 2 years after last participant enrollment.
Overall Survival (OS)
The time from initial treatment to death from any cause
Measured: Approximately 2 years after last participant enrollment.
Adverse Event (AE)
Type, incidence, grading (based on NCI-CTCAE v5.0 criteria), and duration of adverse event.
Measured: Approximately 2 month after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2025
- Study start25 Sep 2025 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jing Hao, Qilu Hospital of Shandong University
- Investigators
- Jing Hao, Deputy Director, Department of Oncology, MD, PhD, Principal investigator, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07156682
- Sponsor's protocol ID
- KYLL-202502-005-1
- Status last verified
- Aug 2025
- First submitted
- 27 Aug 2025
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm, Exploratory Study of Iparomlimab and Tuvonralimab (QL1706) Plus XELOX as Neoadjuvant Therapy in Patients With Microsatellite Stable (pMMR/MSS) Resectable Stage III Colon Cancer
- ClinicalTrials.gov ID
- NCT07156682
- Acronym / sponsor ID
- KYLL-202502-005-1
- Conditions
- Colon Cancer, MSS/pMMR, QL1706
- Keywords
- Iparomlimab and Tuvonralimab, QL1706, Neoadjuvant, MSS/pMMR, Colon Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 25 Sep 2025 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 5 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-arm, exploratory study enrolling participants with resectable stage III pMMR/MSS colon cancer. Eligible participants who provide written informed consent will receive four cycles of neoadjuvant treatment with iparomlimab and tuvonralimab (QL1706) plus XELOX regimen administered every three weeks (Q3W), followed by radical surgery within two weeks after the last neoadjuvant treatment. After surgery, participants will enter the follow-up phase, or clinicians may decide to administer four additional cycles of adjuvant XELOX chemotherapy based on postoperative pathological findings. The primary endpoint of this study is the pathological complete response (pCR) rate as assessed by investigators. Other endpoints include pathological response (PR), major pathological response (MPR), clinical complete response (cCR), event-free survival (EFS), overall survival (OS), and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| QL1706 + XELOX | Experimental | Drug: QL1706, Drug: XELOX |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age between 18 and 75 years.
- Histologically or clinically confirmed initially resectable Stage III colon cancer according to the AJCC 8th edition.
- ECOG performance status of 0 or 1.
- pMMR/MSS status confirmed by a local testing center.
- No planned neoadjuvant radiotherapy.
Key exclusion criteria (10 listed)
- Stage IV colon cancer.
- Prior treatment with immune checkpoint inhibitors targeting CTLA-4, PD-1, or PD-L1.
- Current participation in another clinical trial and receiving investigational drugs.
- History of or contraindication to severe allergic reactions to immunotherapy.
- Pregnancy or lactation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QL1706neoadjuvant administered at a dose of 5 mg/kg, intravenous infusion, every three weeks (Q3W), on day 1 of each cycle, 4 cycles | Drug | QL1706 + XELOX |
| XELOXOxaliplatin 130 mg/m² by intravenous infusion on Day 1; Capecitabine 850-1000 mg/m² orally twice daily (morning and evening) from Day 1 to Day 14; 4 Cycles in total. | Drug | QL1706 + XELOX |
Primary outcome
Pathological Complete Response (pCR)
Time frame: Approximately 1 month after surgery.
No residual viable tumor cells were found in the postoperative pathological assessment.
6 secondary outcomes
Major Pathological Response (MPR)
Time frame: Approximately 1 month after surgery.
Pathological Response (PR)
Time frame: Approximately 1 month after surgery.
Clinical Complete Response (cCR)
Time frame: Approximately 4 months after last participant enrollment.
Event-Free Survival (EFS)
Time frame: Approximately 2 years after last participant enrollment.
Overall Survival (OS)
Time frame: Approximately 2 years after last participant enrollment.
Adverse Event (AE)
Time frame: Approximately 2 month after surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jing Hao, Deputy Director, Department of Oncology, MD, PhD principal investigator
Qilu Hospital of Shandong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing QL1706 and XELOX in people with Colon Cancer and MSS/pMMR, run by Qilu Hospital of Shandong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jian Wang, Dr. (+86 18560088226, wang.jian@sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological Complete Response (pCR) (time frame: Approximately 1 month after surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2025.