mCRCPhase 2NCT07116577
Radiotherapy Combined QL1706, TAS-102 and Bevacizumab in mCRC
A Phase 2 study testing Palliative radiotherapy, Iparomlimab and tuvonralimab and TAS-102 in people with mCRC, run by Jinan Central Hospital at 1 site in China.
Trial summary
This single-center, single-arm, prospective study plans to enroll patients with advanced colorectal cancer who have failed first-line or higher systemic therapies. Participants will receive a combination of iparomlimab and tuvonralimab (QL1706), trifluridine/tipiracil (TAS-102), bevacizumab, and palliative… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- mCRC
- What is being tested?
- Palliative radiotherapy, Iparomlimab and tuvonralimab and TAS-102
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteChina
- Study dates
- 31 Aug 2025to 31 Dec 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
- Aged 18 to 75 years .
- Histologically confirmed unresectable colorectal adenocarcinoma.
- Patients must have received at least one prior line of oxaliplatin-, irinotecan-, or 5-FU-based therapy with documented progression or intolerance.
- Documented KRAS and BRAF mutation status (mutant or wild-type) must be available.
- Palliative radiotherapy targeting primary or metastatic lesions is planned.
- At least one measurable lesion per RECIST v1.1 exists.
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- ECOG score of 0-1 and life expectancy ≥12 weeks.
- Adequate bone marrow, hepatic, and renal function must be demonstrated.
- Fertile patients commit to using effective contraception during and for 6 months post-treatment.
Who cannot join
- History of Grade ≥3 immune-related adverse events (irAEs) from prior immunotherapy deemed contraindications for retreatment.
- Radiation or systemic anticancer therapy within 14 days prior to first study treatment.
- Active CNS metastases and/or leptomeningeal disease (LMD). Symptomatic interstitial lung disease (ILD), active pneumonitis, uncontrolled infections, or non-healing wounds/fistulae.
- Intestinal perforation risks: active diverticulitis, intra-abdominal abscess, GI obstruction, or cancer-related peritoneal carcinomatosis.
- Uncontrolled or symptomatic serous cavity effusions (pleural, ascites, pericardial).
- Uncontrolled cardiovascular/cerebrovascular diseases.
- Medical/social conditions that may compromise study results or lead to premature termination per investigator judgment.
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
Jinan Central Hospital
Jinan, Shandong, 250000
Yawen Zhen, Associate Director, Department of Oncology, +86 150 2001 0760, my123454321@126.com
Meili Sun, Director, Department of Oncology, MD, PhD
About this study
Official title: A Single-Arm, Exploratory Study of Palliative Radiotherapy Combined With Iparomlimab and Tuvonralimab, Trifluridine/Tipiracil (TAS-102), and Bevacizumab in Later-Line Treatment of Advanced Colorectal Cancer
This single-center, single-arm, prospective study plans to enroll patients with advanced colorectal cancer who have failed first-line or higher systemic therapies. Participants will receive a combination of iparomlimab and tuvonralimab (QL1706), trifluridine/tipiracil (TAS-102), bevacizumab, and palliative radiotherapy. The efficacy and safety of this combination therapy will be evaluated by assessing objective response rate (ORR), progression-free survival (PFS), overall survival (OS), disease control rate (DCR), and safety profile.
- Conditions
- mCRC
- Being tested
- Palliative radiotherapy, Iparomlimab and tuvonralimab, TAS-102, Bevacizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palliative radiotherapyRadiation
Conventional fractionation, low-dose hypofractionated radiotherapy, or high-dose hypofractionated radiotherapy may be employed.
Iparomlimab and tuvonralimabDrug
5 mg/kg, intravenously infused on Day 1 of each cycle, administered every 3 weeks (with each cycle defined as 21 days).
TAS-102Drug
35 mg/m², orally twice daily on Days 1 to 5 and Days 8 to 12 of each cycle, with each cycle spanning 28 days (4 weeks).
BevacizumabDrug
7.5 mg/kg via intravenous infusion on Day 1 of each 21-day cycle.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm | Experimental | Palliative radiotherapy combined with iparomlimab and tuvonralimab (QL1706), trifluridine/tipiracil (TAS-102), and bevacizumab. Receives: Radiation: Palliative radiotherapy; Drug: Iparomlimab and tuvonralimab; Drug: TAS-102; Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
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.
Measured: approximately 4 months after the last subject participating in
Secondary outcomes (4)
PFS
the proportion of subjects with complete response (CR) and partial response (PR) according RESIST1.1 in total subjects.
Measured: approximately 12 months after the last subject participating in
OS
The time from the starting date of study drug to the date of death due to any cause.
Measured: approximately 12 months after the last subject participating in
DCR
The proportion of subjects with complete response (CR) and partial response (PR) and stable disease(SD) in total subjects
Measured: approximately 4 months after the last subject participating in
Safety (adverse event)
The rates of adverse events.
Measured: Up to approximately 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start31 Aug 2025 (estimated)
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for mCRCStudies of the same condition, open and under way.
- 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
- 37 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jinan Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meili Sun, Jinan Central Hospital
- Investigators
- Meili Sun, Director, Department of Oncology, MD, PhD,, Principal investigator, Jinan Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07116577
- Sponsor's protocol ID
- 20250710004
- Status last verified
- Aug 2025
- First submitted
- 6 Aug 2025
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm, Exploratory Study of Palliative Radiotherapy Combined With Iparomlimab and Tuvonralimab, Trifluridine/Tipiracil (TAS-102), and Bevacizumab in Later-Line Treatment of Advanced Colorectal Cancer
- ClinicalTrials.gov ID
- NCT07116577
- Acronym / sponsor ID
- 20250710004
- Conditions
- mCRC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- Jinan Central HospitalUniversity, hospital or other
- Study start
- 31 Aug 2025 (estimated)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 11 Aug 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 single-center, single-arm, prospective study plans to enroll patients with advanced colorectal cancer who have failed first-line or higher systemic therapies. Participants will receive a combination of iparomlimab and tuvonralimab (QL1706), trifluridine/tipiracil (TAS-102), bevacizumab, and palliative radiotherapy. The efficacy and safety of this combination therapy will be evaluated by assessing objective response rate (ORR), progression-free survival (PFS), overall survival (OS), disease control rate (DCR), and safety profile.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm | Experimental | Radiation: Palliative radiotherapy, Drug: Iparomlimab and tuvonralimab, Drug: TAS-102, Drug: BevacizumabPalliative radiotherapy combined with iparomlimab and tuvonralimab (QL1706), trifluridine/tipiracil (TAS-102), and bevacizumab. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Aged 18 to 75 years .
- Histologically confirmed unresectable colorectal adenocarcinoma.
- Patients must have received at least one prior line of oxaliplatin-, irinotecan-, or 5-FU-based therapy with documented progression or intolerance.
- Documented KRAS and BRAF mutation status (mutant or wild-type) must be available.
- Palliative radiotherapy targeting primary or metastatic lesions is planned.
Key exclusion criteria (7 listed)
- History of Grade ≥3 immune-related adverse events (irAEs) from prior immunotherapy deemed contraindications for retreatment.
- Radiation or systemic anticancer therapy within 14 days prior to first study treatment.
- Active CNS metastases and/or leptomeningeal disease (LMD). Symptomatic interstitial lung disease (ILD), active pneumonitis, uncontrolled infections, or non-healing wounds/fistulae.
- Intestinal perforation risks: active diverticulitis, intra-abdominal abscess, GI obstruction, or cancer-related peritoneal carcinomatosis.
- Uncontrolled or symptomatic serous cavity effusions (pleural, ascites, pericardial).
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 |
|---|---|---|
| Palliative radiotherapyConventional fractionation, low-dose hypofractionated radiotherapy, or high-dose hypofractionated radiotherapy may be employed. | Radiation | Experimental Arm |
| Iparomlimab and tuvonralimab5 mg/kg, intravenously infused on Day 1 of each cycle, administered every 3 weeks (with each cycle defined as 21 days). | Drug | Experimental Arm |
| TAS-10235 mg/m², orally twice daily on Days 1 to 5 and Days 8 to 12 of each cycle, with each cycle spanning 28 days (4 weeks). | Drug | Experimental Arm |
| Bevacizumab7.5 mg/kg via intravenous infusion on Day 1 of each 21-day cycle. | Drug | Experimental Arm |
Primary outcome
ORR
Time frame: approximately 4 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.
4 secondary outcomes
PFS
Time frame: approximately 12 months after the last subject participating in
OS
Time frame: approximately 12 months after the last subject participating in
DCR
Time frame: approximately 4 months after the last subject participating in
Safety (adverse event)
Time frame: Up to approximately 2 years.
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 11 Aug 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.
Meili Sun, Director, Department of Oncology, MD, PhD, principal investigator
Jinan Central Hospital
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 Palliative radiotherapy, Iparomlimab and tuvonralimab and TAS-102 in people with mCRC, run by Jinan Central Hospital 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 9 inclusion and 7 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 11 Aug 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 Yawen Zhen, Associate Director, Department of Oncology (+86 150 2001 0760, my123454321@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: approximately 4 months after the last subject participating in). 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 11 Aug 2025.