CRCPhase 1/2NCT06195670
Clinical Study of Short-course Radiotherapy Followed by Fruquintinib Plus Sintilimab vs Bevacizumab Plus Capecitabine as First Line Treatment in Advanced mCRC
A Phase 1/2 study testing Experimental and Active Comparator in people with CRC and Metastatic Colorectal Cancer, run by Zhejiang Cancer Hospital at 1 site in China.
Trial summary
The aim of this study is to evaluate the efficacy and safety of short course radiotherapy followed by fruquintinib combined with Sintilimab as the first-line treatment of advanced mCRC compared to bevacizumab combined with capecitabine in patients unfit for intensive therapy. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- CRC, Metastatic Colorectal Cancer, Metastatic Colorectal Adenocarcinoma
- What is being tested?
- Experimental and Active Comparator
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteChina
- Study dates
- Jan 2024to Jan 2027
- Phase
- Phase 1/2
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have signed an informed consent;
- 18 to 85 years old (including 18 and 85 years old);
- Histopathologically confirmed unresectable advanced metastatic colorectal adenocarcinoma;
- Have not received anti-tumor treatment for metastatic disease;
- Inability to tolerate intensive treatment regimens based on oxaliplatin or irinotecan as determined by researchers;
- At least one measurable lesion;
Show all 17Show fewer
- Expected life expectancy ≥ 12 weeks;
- The function of important organs within the 14 days prior to enrollment meets the following requirements (no blood components or cell growth factors are allowed to be used within the 14 days prior to enrollment):
- Neutrophil absolute count ≥ 1.5 × 10^9/L;
- Platelets ≥ 80 × 10^9/L;
- Hemoglobin ≥ 8g/dL;
- Total bilirubin<1.5 times ULN;
- ALT and AST<2.5 times ULN (liver metastasis patients<5 times ULN);
- Serum creatinine ≤ 1.5 times ULN;
- Endogenous creatinine clearance rate>50ml/min;
- International standardized ratio (INR) of coagulation function ≤ 1.5 × ULN, prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN
- Women of childbearing age or men whose partners have a desire to conceive should take effective contraceptive measures.
Who cannot join
- Currently has a disease or condition that affects drug absorption, or the patient is unable to take oral drugs;
- Currently has digestive tract diseases such as active gastric and duodenal ulcers, ulcerative colitis, or active bleeding from unresectable tumors, or other conditions determined by the researcher that may cause gastrointestinal bleeding or perforation;
- History of serious cardiovascular and cerebrovascular diseases;
- Other malignant tumors within the past 5 years, excluding skin basal cell or squamous cell carcinoma after radical surgery, or cervical carcinoma in situ;
- Clinically uncontrolled active infection, such as acute pneumonia, active hepatitis B or hepatitis C (hepatitis B virus DNA ≥ 1 × 104 copies/mL or>2000 IU/ml);
- Currently has central nervous system (CNS) metastasis or has a history of unstable or clinically symptomatic brain metastasis;
Show all 10Show fewer
- Pregnant (positive pregnancy test before medication) or breastfeeding women;
- Urine protein ≥ 2+, or 24-hour urine protein >1.0g;
- Histologically confirmed MSI-H/dMMR tumors;
- Patients deemed unsuitable by the researchers for inclusion in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: An Open-label, Multi-centered, Two-stage Clinical Study of Short-course Radiotherapy Followed by Fruquintinib Plus Sintilimab vs Bevacizumab Plus Capecitabine in the First Line Treatment of Advanced mCRC Patients Unfit for Intense Therapy
The aim of this study is to evaluate the efficacy and safety of short course radiotherapy followed by fruquintinib combined with Sintilimab as the first-line treatment of advanced mCRC compared to bevacizumab combined with capecitabine in patients unfit for intensive therapy.
Read the detailed description
Anti-angiogenic therapy combined with immune checkpoint inhibitors in advanced mCRC has shown promising efficacy with acceptable toxicities. Radiotherapy may reshape the tumor immune microenvironment, thereby improving the efficacy of subsequent anti angiogenic drugs combined with immunotherapy.
The study is a prospective, multi-centered, two-stage clinical study with 220 unresectable advanced mCRC patients unfit for oxaliplatin or irinotecan-based intensive chemotherapy enrolled. In phase 1b, 20 patients will be recruited and the efficacy and safety of SCRT followed by fruquintinib plus sintilimab will be explored. In phase 2, 200 patients will be randomized and the efficacy and safety will be compared between SCRT followed by fruquintinib plus sintilimab and capecitabine plus bevacizumab.
- Being tested
- Experimental, Active Comparator
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExperimentalDrug
Also called SCRT + fruquintinib + sintilimab
SCRT: 5*5Gy for 5 days, after a one-week rest, with fruquintinib plus sintilimab followed; Fruquintinib: qd po, 4mg/d, 2weeks on/1 week off, q3w; Sintilimab: intravenous infusion, 200mg, on day 1, q3w.
Active ComparatorDrug
Also called Bevacizumab + Capecitabine
Capecitabine: bid po, 1000mg/m², on days 1-14, q3w; Bevacizumab: intravenous infusion, 7.5mg/kg, on day 1, q3w.
| Study group | Role | What they receive |
|---|---|---|
| SCRT + fruquintinib + sintilimab | Experimental | Not described Receives: Drug: Experimental |
| Bevacizumab + Capecitabine | Active comparator | Not described Receives: Drug: Active Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1b - Objective Response Rate (ORR)
ORR according to RECIST v1.1, as assessed by the Investigator
Measured: From randomization until disease progression (up to approximately 3-5 years)
Phase 2 - Progression-free Survival (PFS)
PFS according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, as assessed by the Investigator
Measured: From randomization until disease progression (up to approximately 3-5 years)
Secondary outcomes (3)
Tolerability and safety of study regimens
Number of Participants With Treatment-emergent Adverse Events (TEAEs) according to CTCAE v5.0
Measured: From randomization until the end of treatment (up to approximately 3-5 years)
Disease Control Rate (DCR)
DCR according to RECIST v1.1, as assessed by the Investigator
Measured: From randomization until disease progression (up to approximately 3-5 years)
Overall Survival OS)
OS according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, as assessed by the Investigator
Measured: From randomization until disease progression (up to approximately 3-5 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2024
- Study startJan 2024 (estimated)
- Primary completionJan 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CRCStudies of the same condition, open and under way.
- More trials run by Zhejiang Cancer HospitalThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji Zhu, Zhejiang Cancer Hospital
- Investigators
- Ji Zhu, M.D., Principal investigator, Zhejiang Cancer HospitalZhong Shi, M.D., Principal investigator, Zhejiang Cancer HospitalWangxia Lv, M.D., Principal investigator, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06195670
- Sponsor's protocol ID
- HMPL-013-FLAG-C124
- Status last verified
- Dec 2023
- First submitted
- 22 Dec 2023
- Last updated
- 8 Jan 2024
- 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 8 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multi-centered, Two-stage Clinical Study of Short-course Radiotherapy Followed by Fruquintinib Plus Sintilimab vs Bevacizumab Plus Capecitabine in the First Line Treatment of Advanced mCRC Patients Unfit for Intense Therapy
- ClinicalTrials.gov ID
- NCT06195670
- Acronym / sponsor ID
- HMPL-013-FLAG-C124
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- Jan 2024 (estimated)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 8 Jan 2024 (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.
The aim of this study is to evaluate the efficacy and safety of short course radiotherapy followed by fruquintinib combined with Sintilimab as the first-line treatment of advanced mCRC compared to bevacizumab combined with capecitabine in patients unfit for intensive therapy.
Detailed description
Anti-angiogenic therapy combined with immune checkpoint inhibitors in advanced mCRC has shown promising efficacy with acceptable toxicities. Radiotherapy may reshape the tumor immune microenvironment, thereby improving the efficacy of subsequent anti angiogenic drugs combined with immunotherapy.
The study is a prospective, multi-centered, two-stage clinical study with 220 unresectable advanced mCRC patients unfit for oxaliplatin or irinotecan-based intensive chemotherapy enrolled. In phase 1b, 20 patients will be recruited and the efficacy and safety of SCRT followed by fruquintinib plus sintilimab will be explored. In phase 2, 200 patients will be randomized and the efficacy and safety will be compared between SCRT followed by fruquintinib plus sintilimab and capecitabine plus bevacizumab.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SCRT + fruquintinib + sintilimab | Experimental | Drug: Experimental |
| Bevacizumab + Capecitabine | Active comparator | Drug: Active Comparator |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Have signed an informed consent;
- 18 to 85 years old (including 18 and 85 years old);
- Histopathologically confirmed unresectable advanced metastatic colorectal adenocarcinoma;
- Have not received anti-tumor treatment for metastatic disease;
- Inability to tolerate intensive treatment regimens based on oxaliplatin or irinotecan as determined by researchers;
Key exclusion criteria (10 listed)
- Currently has a disease or condition that affects drug absorption, or the patient is unable to take oral drugs;
- Currently has digestive tract diseases such as active gastric and duodenal ulcers, ulcerative colitis, or active bleeding from unresectable tumors, or other conditions determined by the researcher that may cause gastrointestinal bleeding or perforation;
- History of serious cardiovascular and cerebrovascular diseases;
- Other malignant tumors within the past 5 years, excluding skin basal cell or squamous cell carcinoma after radical surgery, or cervical carcinoma in situ;
- Clinically uncontrolled active infection, such as acute pneumonia, active hepatitis B or hepatitis C (hepatitis B virus DNA ≥ 1 × 104 copies/mL or>2000 IU/ml);
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 |
|---|---|---|
| ExperimentalAlso: SCRT + fruquintinib + sintilimabSCRT: 5*5Gy for 5 days, after a one-week rest, with fruquintinib plus sintilimab followed; Fruquintinib: qd po, 4mg/d, 2weeks on/1 week off, q3w; Sintilimab: intravenous infusion, 200mg, on day 1, q3w. | Drug | SCRT + fruquintinib + sintilimab |
| Active ComparatorAlso: Bevacizumab + CapecitabineCapecitabine: bid po, 1000mg/m², on days 1-14, q3w; Bevacizumab: intravenous infusion, 7.5mg/kg, on day 1, q3w. | Drug | Bevacizumab + Capecitabine |
Primary outcome
Phase 1b - Objective Response Rate (ORR)
Time frame: From randomization until disease progression (up to approximately 3-5 years)
ORR according to RECIST v1.1, as assessed by the Investigator
Phase 2 - Progression-free Survival (PFS)
Time frame: From randomization until disease progression (up to approximately 3-5 years)
PFS according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, as assessed by the Investigator
3 secondary outcomes
Tolerability and safety of study regimens
Time frame: From randomization until the end of treatment (up to approximately 3-5 years)
Disease Control Rate (DCR)
Time frame: From randomization until disease progression (up to approximately 3-5 years)
Overall Survival OS)
Time frame: From randomization until disease progression (up to approximately 3-5 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 8 Jan 2024.
- Individual participant dataSharing planned: No
Related trials for CRC
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
Not yet recruitingPhase 2
Alberta Cancer Exercise Dose in Colorectal Cancer
Cancer, Colorectal Cancer
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.
Ji Zhu, M.D. principal investigator
Zhejiang Cancer Hospital
Zhong Shi, M.D. principal investigator
Zhejiang Cancer Hospital
Wangxia Lv, M.D. principal investigator
Zhejiang Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Experimental and Active Comparator in people with CRC and Metastatic Colorectal Cancer, run by Zhejiang Cancer 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 17 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 8 Jan 2024. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Ji Zhu, M.D. (0571-88128142 ext +86, leozhu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1b - Objective Response Rate (ORR) (time frame: From randomization until disease progression (up to approximately 3-5 years)). The study lists 2 primary outcomes in all. 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 8 Jan 2024.