Colorectal CarcinomaPhase 2NCT05799820
QL1706 Monotherapy or in Combination With Bevacizumab and XELOX as First-line Treatment of Unresectable Advanced or Metastatic CRC
A Phase 2 study testing QL1706, Bevacizumab and Oxaliplatin injection in people with Colorectal Carcinoma, run by Qilu Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This is an open-label, muticenter phase II study to evaluate the efficacy and safety of QL1706 monotherapy or in combination with bevacizumab and XELOX as first-line treatment of unresectable advanced or metastatic CRC. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colorectal Carcinoma
- What is being tested?
- QL1706, Bevacizumab and Oxaliplatin injection
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 29 Sep 2022to 30 Sep 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Subjects participate voluntarily and sign informed consent.
- 2. Age ≥ 18 and ≤ 80 years old, male or female.
- 3. Histologically confirmed unresectable locally advanced or metastatic adenocarcinoma of the colon or rectum.
- 4. At least 1 measurable target lesion according to Response Evaluation in Solid Tumors (RECIST 1.1).
Who cannot join
- 1. Diagnosed additional maliganancy within 5 years with the expection of curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin,curatively resected in situ cervival or non-muscle invasive bladder cancers.
- 2. Presence of brain metastases (asymptomatic brain metastases or symptomatic brain metastases who are stable at least 4 weeks, were allowed to be enrolled).
- 3. Has active autoimmune disease that has required systemic treatment in past 2 years.
- 4. Significant cardiovascular disease.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai East Hospital
Shanghai, Shanghai Municipality, 200120
Jin Li, 021-38804518
About this study
Official title: An Open-label, Multicenter Phase II Study of QL1706 Monotherapy or in Combination With Bevacizumab and XELOX as First-line Treatment of Unresectable Advanced or Metastatic CRC
This is an open-label, muticenter phase II study to evaluate the efficacy and safety of QL1706 monotherapy or in combination with bevacizumab and XELOX as first-line treatment of unresectable advanced or metastatic CRC.
- Conditions
- Colorectal Carcinoma
- Being tested
- QL1706, Bevacizumab, Oxaliplatin injection, Capecitabine
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QL1706Drug
5 mg/kg administered as IV infusion on Day 1 of each 21-day cycle
BevacizumabDrug
7.5 mg/kg administered as IV infusion on Day 1 of each 21-day cycle
Oxaliplatin injectionDrug
130mg/m2 administered as IV infusion on Day 1 of each 21-day cycle
CapecitabineDrug
1000 mg/m2 orally twice daily for 14 days continuous dosing followed by a 7-day break of each 21-day cycle
| Study group | Role | What they receive |
|---|---|---|
| QL1706 | Experimental | Not described Receives: Drug: QL1706 |
| QL1706 in combination with bevacizumab and XELOX | Experimental | Not described Receives: Drug: QL1706; Drug: Bevacizumab; Drug: Oxaliplatin injection; Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
ORR was assessed by investigators per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).
Measured: Up to approximately 2 years
Secondary outcomes (4)
Disease Control Rate (DCR)
DCR was assessed by investigators per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).
Measured: Up to approximately 2 years
Duration of Response (DOR)
DOR was assessed by investigators per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).
Measured: Up to approximately 2 years
Progression-free Survival (PFS)
PFS was assessed by investigators per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).
Measured: Up to approximately 2 years
Overall Survival (OS)
OS was defined as the time from randomization to death due to any cause.
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 posted5 Apr 2023
- Study start29 Sep 2022
- Primary completion30 Mar 2024 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CarcinomaStudies of the same condition, open and under way.
- More trials run by Qilu Pharmaceutical Co., Ltd.The 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jin Li, MD, Principal investigator, Shanghai East Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05799820
- Sponsor's protocol ID
- QL1706-208
- Status last verified
- Mar 2023
- First submitted
- 23 Mar 2023
- Last updated
- 25 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multicenter Phase II Study of QL1706 Monotherapy or in Combination With Bevacizumab and XELOX as First-line Treatment of Unresectable Advanced or Metastatic CRC
- ClinicalTrials.gov ID
- NCT05799820
- Acronym / sponsor ID
- QL1706-208
- Conditions
- Colorectal Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 Sep 2022 (actual)
- Primary completion
- 30 Mar 2024 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 5 Apr 2023 (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 an open-label, muticenter phase II study to evaluate the efficacy and safety of QL1706 monotherapy or in combination with bevacizumab and XELOX as first-line treatment of unresectable advanced or metastatic CRC.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| QL1706 | Experimental | Drug: QL1706 |
| QL1706 in combination with bevacizumab and XELOX | Experimental | Drug: QL1706, Drug: Bevacizumab, Drug: Oxaliplatin injection, Drug: Capecitabine |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 1. Subjects participate voluntarily and sign informed consent.
- 2. Age ≥ 18 and ≤ 80 years old, male or female.
- 3. Histologically confirmed unresectable locally advanced or metastatic adenocarcinoma of the colon or rectum.
- 4. At least 1 measurable target lesion according to Response Evaluation in Solid Tumors (RECIST 1.1).
Key exclusion criteria (4 listed)
- 1. Diagnosed additional maliganancy within 5 years with the expection of curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin,curatively resected in situ cervival or non-muscle invasive bladder cancers.
- 2. Presence of brain metastases (asymptomatic brain metastases or symptomatic brain metastases who are stable at least 4 weeks, were allowed to be enrolled).
- 3. Has active autoimmune disease that has required systemic treatment in past 2 years.
- 4. Significant cardiovascular disease.
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 |
|---|---|---|
| QL17065 mg/kg administered as IV infusion on Day 1 of each 21-day cycle | Drug | QL1706, QL1706 in combination with bevacizumab and XELOX |
| Bevacizumab7.5 mg/kg administered as IV infusion on Day 1 of each 21-day cycle | Drug | QL1706 in combination with bevacizumab and XELOX |
| Oxaliplatin injection130mg/m2 administered as IV infusion on Day 1 of each 21-day cycle | Drug | QL1706 in combination with bevacizumab and XELOX |
| Capecitabine1000 mg/m2 orally twice daily for 14 days continuous dosing followed by a 7-day break of each 21-day cycle | Drug | QL1706 in combination with bevacizumab and XELOX |
Primary outcome
Objective Response Rate (ORR)
Time frame: Up to approximately 2 years
ORR was assessed by investigators per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).
4 secondary outcomes
Disease Control Rate (DCR)
Time frame: Up to approximately 2 years
Duration of Response (DOR)
Time frame: Up to approximately 2 years
Progression-free Survival (PFS)
Time frame: Up to approximately 2 years
Overall Survival (OS)
Time frame: Up to approximately 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Jin Li, MD principal investigator
Shanghai East 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 QL1706, Bevacizumab and Oxaliplatin injection in people with Colorectal Carcinoma, run by Qilu Pharmaceutical Co., Ltd. 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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 25 May 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jin Li, MD (+86 021-38804518, lijin@csco.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: Up to approximately 2 years). 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 25 May 2023.