Refractory Metastatic Colorectal CancerPhase 3NCT07361003
A Phase Ib/III Study of Suvemcitug Plus FTD/TPI in Participants With Refractory Metastatic Colorectal Cancer
A Phase 3 study testing Suvemcitug injection, trifluridine/tipiracil tablets in people with Refractory Metastatic Colorectal Cancer, run by Jiangsu Simcere Pharmaceutical Co., Ltd. at 6 sites in China.
Trial summary
The primary goal of Phase Ib Study is to evaluate the safety of Suvemcitug in combination with trifluridine/tipiracil tablets in colorectal cancer participants. The primary goal of Phase III Study is to evaluate the efficacy of Suvemcitug in combination with trifluridine/tipiracil tablets in colorectal cancer… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractory Metastatic Colorectal Cancer
- What is being tested?
- Suvemcitug injection, trifluridine/tipiracil tablets
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 464 participants
- Where
- 6 sitesChina
- Study dates
- 12 Nov 2025to Jul 2028
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Confirmed by histological and/or cytological examination as unresectable metastatic colon or rectal adenocarcinoma;
- 2. At least one measurable tumor lesion (RECIST v1.1);
- 3. Previously received fluorouracil, oxaliplatin, and irinotecan based chemotherapy; had previously undergone or was unsuitable for anti-VEGF therapy. (For participants with RAS wild-type, had previously undergone or was unsuitable for anti-EGFR therapy.);
- 4. Refractory metastatic colorectal cancer having progressed on or are intolerant to the last systemic treatment;
- 5. Good organ and bone marrow function (no administration of hematopoietic growth factors, blood transfusion, or platelets within 14 days before screening hematology test);
- 6. RAS mutation status confirmed by testing tumor tissue and /or blood sample.
Who cannot join
- 1. Having a second active primary malignancy within the past 5 years;
- 2. Symptomatic central nervous system (CNS) metastases or CNS metastases requiring local CNS-directed therapy (e.g., radiotherapy or surgery) or corticosteroid treatment within 2 weeks prior to the first administration of the study treatment;
- 3. Any active infection requiring systemic treatment within 2 weeks prior to the initiation of the study treatment;
- 4. Pleural effusion, pericardial effusion, or ascites that is uncontrolled or has required drainage or medical intervention within 4 weeks prior to the first administration of the study treatment;
- 5. Received systemic immuno suppressive therapy within 4 weeks prior to randomization (excluding prophylactic use or chronic low-dose steroids [≤20 mg/day prednisone equivalent dose]);
- 6. Currently taking or has recently taken (within 10 days prior to the first dose) aspirin (>325 mg/day);
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- 7. Active or chronic hepatitis B (HBsAg or HBcAb positive and HBV DNA≥2000 IU/mL or ≥10000 copies/mL) or hepatitis C infection (HCV antibody positive and HCV RNA≥ULN);
- 8. Clinically significant cardiovascular disease within 6 months prior to the first administration of the study treatment;symptomatic coronary artery disease requiring medication; arrhythmia requiring medication (excluding asymptomatic atrial fibrillation with controlled ventricular rate); QTcF interval >470 ms at rest state; or uncontrolled hypertension or pulmonary hypertension;
- 9. Known hereditary or acquired bleeding and thrombotic tendencies (e.g., hemophilia, coagulation disorders, thrombocytopenia, hypersplenism, etc.); clinically significant bleeding events, arterial or deep venous thrombotic events, or superficial venous thrombosis and intermuscular venous thrombosis requiring intervention within 6 months prior to enrollment;
- 10. Participants with proteinuria (urine protein >2+ found during screening examinations; or urine protein 2+ with 24-hour urine protein quantification ≥1g/24h);
- 11. Participants with a history of intestinal obstruction (including incomplete intestinal obstruction) within 1 month prior to enrollment; participants with a history of abdominal fistula, gastrointestinal perforation, or abdominal abscess.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
China6 sites, 6 recruiting
- Recruiting
Fujian Cancer Hospital
Fuzhou, Fujian, 350014
Rongbo Lin, +86-591-83660063, linrongbo@fjzlhospital.com
Rongbo Lin
- Recruiting
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
Kefeng Ding, +86-571-87783777, dingkefeng@zju.edu.cn
Kefeng Ding
- Recruiting
Harbin Medical University University Cancer Hospital
Harbin, Heilongjiang
Yanqiao Zhang, +86-451-86298000, yanqiaozhang@126.com
Yanqiao Zhang
- Recruiting
Cancer Hospital of Shandong First Medical University
Jinan, Shandong
Shuqin Ni, 0086-0531-87984777, nsq163@163.com
Shuqin Ni
- Recruiting
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029
Yanhong Gu, +86-25-83714511, guluer@163.com
Yanhong Gu
- Recruiting
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality
Ting Deng, 86-22-23359337, xymcdengting@126.com
Ting Deng
About this study
Official title: A Phase Ib/III Study of Suvemcitug Plus Trifluridine/Tipiracil Tablets (FTD/TPI) Versus Placebo Plus Trifluridine/Tipiracil Tablets in Participants With Refractory Metastatic Colorectal Cancer
The primary goal of Phase Ib Study is to evaluate the safety of Suvemcitug in combination with trifluridine/tipiracil tablets in colorectal cancer participants.
The primary goal of Phase III Study is to evaluate the efficacy of Suvemcitug in combination with trifluridine/tipiracil tablets in colorectal cancer participants. Researchers will compare Suvemcitug + trifluridine/tipiracil tablets with placebo (a look-alike substance that contains no drug)+ trifluridine/tipiracil tablets to see if Suvemcitug + trifluridine/tipiracil tablets works better in treating refractory metastatic colorectal cancer.
Read the detailed description
The study will enroll approximately 464 participants (30 for Phase Ib and 434 for Phase III stage) with refractory metastatic colorectal cancer who have previously received fluorouracil, oxaliplatin, and irinotecan-based chemotherapy, and who have either previously received or are unsuitable for anti-vascular endothelial growth factor (VEGF) therapy or anti-epidermal growth factor receptor (EGFR) therapy (RAS wild-type).
For Phase Ib Study, all 30 participants will be receiving the treatment with Suvemcitug in combination with trifluridine/tipiracil tablets. For Phase III Study, approximately 434 participants will be randomly assigned in a 1:1 ratio to two groups. One group will receive treatment with Suvemcitug + trifluridine/tipiracil tablets. The other group will receive the treatment with placebo + trifluridine/tipiracil tablets.
All participants will receive study treatment until they meet the criteria for treatment discontinuation. During study treatment period, investigators will evaluate the efficacy, safety and participants' quality of life. After treatment discontinuation, investigators will continue to follow up for subsequent treatment and survival information until the criteria for study discontinuation are met.
By the end of study, for participants who are still receiving study treatment, if their efficacy evaluation result is stable or response and they are tolerant to the treatment, then after obtaining approval from health regulatory authorities and ethics committees, they can continue study treatment by joining another extension study or in other ways as discussed by the sponsor.
- Conditions
- Refractory Metastatic Colorectal Cancer
- Being tested
- Suvemcitug injection, trifluridine/tipiracil tablets, Suvemcitug placebo injection, trifluridine/tipiracil tablets
- Keywords
- refractory metastatic colorectal cancer, Suvemcitug, trifluridine/tipiracil
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suvemcitug injection, trifluridine/tipiracil tabletsDrug
Suvemcitug injection at 1.5mg/kg, Trifluridine/tipiracil tablets at 35 mg/m²
Suvemcitug placebo injection, trifluridine/tipiracil tabletsDrug
Suvemcitug placebo injection, Trifluridine/tipiracil tablets at 35 mg/m².
| Study group | Role | What they receive |
|---|---|---|
| Suvemcitug+ trifluridine/tipiracil tablets | Experimental | Participants will receive Suvemcitug injection (at 1.5mg/kg for Phase Ib; and a recommended dose level based on Phase Ib result will be used for Phase III part) on Day 1 and Day 15 of each cycle (28 days), and trifluridine/tipiracil tablets at 35 mg/m² on day 1-5, 8-12 of each cycle (28 days), until disease progression, intolerable adverse event, participant withdrawal, or meet other discontinuation criteria as described by the protocol. Receives: Drug: Suvemcitug injection, trifluridine/tipiracil tablets |
| Placebo+ trifluridine/tipiracil tablets | Placebo comparator | Participants will receive Suvemcitug placebo injection on Day 1 and Day 15 of each cycle (28 days), and trifluridine/tipiracil tablets at 35 mg/m² on day 1-5, 8-12 of each cycle (28 days), until disease progression, intolerable adverse event, participant withdrawal, or meet other discontinuation criteria as described by the protocol. Receives: Drug: Suvemcitug placebo injection, trifluridine/tipiracil tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase Ib: dose limiting toxicity (DLT)
Measured: At the end of Cycle 1 (each cycle is 28 days)
Phase Ib: Adverse Events
The incidence (number of participants) and severity of adverse events (AE) and serious adverse events (SAE) assessed by CTCAE v5.0
Measured: From signing informed consent form until 28 days after the last dose of study treatment, up to about 18 months
Phase Ib: Tolerance
Number of participants who experienced adverse event related dose interruption, dose reduction and treatment discontinuation as assessed by investigators.
Measured: From signing informed consent until 28 days after the last dose of study treatment, for up to 18 months
Phase III: overall survival (OS)
OS is the time interval from the date of randomization to death from any cause.
Measured: For about 18 months from the randomization of the last participant
Secondary outcomes (15)
Suvemcitug Serum concentration change over time of all participants
Area under the serum concentration versus time curve (AUC)
Measured: For about 6 cycles, each cycle is 28 days.
Peak Suvemcitug serum concentration (Cmax) of all participants
Measured: For about 6 cycles, each cycle is 28 days
The time taken to reach peak Suvemcitug concentration after administration (Tmax)
Measured: For about 6 cycles, each cycle is 28 days
The time required for Suvemcitug concentration in the serum to decrease by half (t1/2)
Measured: For about 6 cycles, each cycle is 28 days
Serum anti-drug antibody (ADA) incidence of Suvemcitug
The number of participants with anti-drug antibody (ADA) tested positive from blood
Measured: For about 6 cycles, each cycle is 28 days
Serum anti-drug antibody (ADA) duration of Suvemcitug
Duration of ADA measures how long the antibody persists in the blood
Measured: For about 6 cycles, each cycle is 28 days
Serum anti-drug antibody (ADA) titer of Suvemcitug
ADA titer measures how much anti-drug antibody is present in the blood
Measured: For about 6 cycles, each cycle is 28 days
Objective Response Rate (ORR) of all participants
Proportion of participants who have a complete or partial response relative to baseline as assessed according to RECIST 1.1 criteria
Measured: From the date when the first dose of Suvemcitug is administered until radiological progression, initiation of new anti-cancer therapy, death or withdrawal from study, whichever came first, assessed up to 18 months.
Duration of response (DoR) of all participants
Measured from the date of partial or complete response to therapy until the cancer progresses based on RECIST v1.1 criteria.
Measured: From the date when the first dose of Suvemcitug is administered until radiological progression, initiation of new anti-cancer therapy, death or withdrawal from study, whichever came first, assessed up to 18 months
Disease control rate (DCR) of all participants
Proportion of participants who have a complete or partial response, or stable disease relative to baseline as assessed according to RECIST 1.1 criteria
Measured: From the date when the first dose of Suvemcitug is administered until radiological progression, initiation of new anti-cancer therapy, death or withdrawal from study, whichever came first, assessed up to 18 months.
Progression free survival (PFS) of all participants
Measured: From the date when the first dose of Suvemcitug is administered until radiological progression, initiation of new anti-cancer therapy, death or withdrawal from study, whichever came first, assessed up to 18 months.
Phase Ib: overall survival (OS)
OS is the time interval from the date of randomization to death from any cause
Measured: For about 18 months from the randomization of the last participant
Phase III: Adverse Events
The incidence (number of participants) and severity of adverse events (AE) and serious adverse events (SAE) assessed by CTCAE v5.0
Measured: From signing informed consent form until 28 days after the last dose of study treatment, for about 18 months.
Phase III: quality of life - EORTC QLQ-C30
Quality of life evaluated by participant reported questionnaires: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 .
Measured: Questionnaires will be collected from participants at baseline, and all efficacy evaluation visits, for up to 18 months
Phase III: quality of life - Euro Qol (EQ)-5D
Evaluated by participant reported questionnaires: EuroQol- 5 Dimension Questionnaire.
Measured: Questionnaires will be collected from participants at baseline, and all efficacy evaluation visits, for up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start12 Nov 2025
- Primary completionJan 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory Metastatic Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Jiangsu Simcere 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is divided into two parts: the first part (Phase Ib) is open-label, and the second part (Phase III) is a randomized double-blind study. This study is currently in the first part.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 464 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Jiangsu Simcere Biologics Co., Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07361003
- Sponsor's protocol ID
- SIM0063-302
- Other IDs
- CTR20254831
- Status last verified
- Dec 2025
- First submitted
- 30 Sep 2025
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib/III Study of Suvemcitug Plus Trifluridine/Tipiracil Tablets (FTD/TPI) Versus Placebo Plus Trifluridine/Tipiracil Tablets in Participants With Refractory Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT07361003
- Acronym / sponsor ID
- SIM0063-302
- Conditions
- Refractory Metastatic Colorectal Cancer
- Keywords
- refractory metastatic colorectal cancer, Suvemcitug, trifluridine/tipiracil
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 464 participants (estimated)
- Lead sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Jiangsu Simcere Biologics Co., Ltd
- Study start
- 12 Nov 2025 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 22 Jan 2026 (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 primary goal of Phase Ib Study is to evaluate the safety of Suvemcitug in combination with trifluridine/tipiracil tablets in colorectal cancer participants.
The primary goal of Phase III Study is to evaluate the efficacy of Suvemcitug in combination with trifluridine/tipiracil tablets in colorectal cancer participants. Researchers will compare Suvemcitug + trifluridine/tipiracil tablets with placebo (a look-alike substance that contains no drug)+ trifluridine/tipiracil tablets to see if Suvemcitug + trifluridine/tipiracil tablets works better in treating refractory metastatic colorectal cancer.
Detailed description
The study will enroll approximately 464 participants (30 for Phase Ib and 434 for Phase III stage) with refractory metastatic colorectal cancer who have previously received fluorouracil, oxaliplatin, and irinotecan-based chemotherapy, and who have either previously received or are unsuitable for anti-vascular endothelial growth factor (VEGF) therapy or anti-epidermal growth factor receptor (EGFR) therapy (RAS wild-type).
For Phase Ib Study, all 30 participants will be receiving the treatment with Suvemcitug in combination with trifluridine/tipiracil tablets. For Phase III Study, approximately 434 participants will be randomly assigned in a 1:1 ratio to two groups. One group will receive treatment with Suvemcitug + trifluridine/tipiracil tablets. The other group will receive the treatment with placebo + trifluridine/tipiracil tablets.
All participants will receive study treatment until they meet the criteria for treatment discontinuation. During study treatment period, investigators will evaluate the efficacy, safety and participants' quality of life. After treatment discontinuation, investigators will continue to follow up for subsequent treatment and survival information until the criteria for study discontinuation are met.
By the end of study, for participants who are still receiving study treatment, if their efficacy evaluation result is stable or response and they are tolerant to the treatment, then after obtaining approval from health regulatory authorities and ethics committees, they can continue study treatment by joining another extension study or in other ways as discussed by the sponsor.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This study is divided into two parts: the first part (Phase Ib) is open-label, and the second part (Phase III) is a randomized double-blind study. This study is currently in the first part.
| Arm | Type | Receives |
|---|---|---|
| Suvemcitug+ trifluridine/tipiracil tablets | Experimental | Drug: Suvemcitug injection, trifluridine/tipiracil tabletsParticipants will receive Suvemcitug injection (at 1.5mg/kg for Phase Ib; and a recommended dose level based on Phase Ib result will be used for Phase III part) on Day 1 and Day 15 of each cycle (28 days), and trifluridine/tipiracil tablets at 35 mg/m² on day 1-5, 8-12 of each cycle (28 days), until disease progression, intolerable adverse event, participant withdrawal, or meet other discontinuation criteria as described by the protocol. |
| Placebo+ trifluridine/tipiracil tablets | Placebo comparator | Drug: Suvemcitug placebo injection, trifluridine/tipiracil tabletsParticipants will receive Suvemcitug placebo injection on Day 1 and Day 15 of each cycle (28 days), and trifluridine/tipiracil tablets at 35 mg/m² on day 1-5, 8-12 of each cycle (28 days), until disease progression, intolerable adverse event, participant withdrawal, or meet other discontinuation criteria as described by the protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 1. Confirmed by histological and/or cytological examination as unresectable metastatic colon or rectal adenocarcinoma;
- 2. At least one measurable tumor lesion (RECIST v1.1);
- 3. Previously received fluorouracil, oxaliplatin, and irinotecan based chemotherapy; had previously undergone or was unsuitable for anti-VEGF therapy. (For participants with RAS wild-type, had previously undergone or was unsuitable for anti-EGFR therapy.);
- 4. Refractory metastatic colorectal cancer having progressed on or are intolerant to the last systemic treatment;
- 5. Good organ and bone marrow function (no administration of hematopoietic growth factors, blood transfusion, or platelets within 14 days before screening hematology test);
Key exclusion criteria (11 listed)
- 1. Having a second active primary malignancy within the past 5 years;
- 2. Symptomatic central nervous system (CNS) metastases or CNS metastases requiring local CNS-directed therapy (e.g., radiotherapy or surgery) or corticosteroid treatment within 2 weeks prior to the first administration of the study treatment;
- 3. Any active infection requiring systemic treatment within 2 weeks prior to the initiation of the study treatment;
- 4. Pleural effusion, pericardial effusion, or ascites that is uncontrolled or has required drainage or medical intervention within 4 weeks prior to the first administration of the study treatment;
- 5. Received systemic immuno suppressive therapy within 4 weeks prior to randomization (excluding prophylactic use or chronic low-dose steroids [≤20 mg/day prednisone equivalent dose]);
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 |
|---|---|---|
| Suvemcitug injection, trifluridine/tipiracil tabletsSuvemcitug injection at 1.5mg/kg, Trifluridine/tipiracil tablets at 35 mg/m² | Drug | Suvemcitug+ trifluridine/tipiracil tablets |
| Suvemcitug placebo injection, trifluridine/tipiracil tabletsSuvemcitug placebo injection, Trifluridine/tipiracil tablets at 35 mg/m². | Drug | Placebo+ trifluridine/tipiracil tablets |
Primary outcome
Phase Ib: dose limiting toxicity (DLT)
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Phase Ib: Adverse Events
Time frame: From signing informed consent form until 28 days after the last dose of study treatment, up to about 18 months
The incidence (number of participants) and severity of adverse events (AE) and serious adverse events (SAE) assessed by CTCAE v5.0
Phase Ib: Tolerance
Time frame: From signing informed consent until 28 days after the last dose of study treatment, for up to 18 months
Number of participants who experienced adverse event related dose interruption, dose reduction and treatment discontinuation as assessed by investigators.
Phase III: overall survival (OS)
Time frame: For about 18 months from the randomization of the last participant
OS is the time interval from the date of randomization to death from any cause.
15 secondary outcomes
Suvemcitug Serum concentration change over time of all participants
Time frame: For about 6 cycles, each cycle is 28 days.
Peak Suvemcitug serum concentration (Cmax) of all participants
Time frame: For about 6 cycles, each cycle is 28 days
The time taken to reach peak Suvemcitug concentration after administration (Tmax)
Time frame: For about 6 cycles, each cycle is 28 days
The time required for Suvemcitug concentration in the serum to decrease by half (t1/2)
Time frame: For about 6 cycles, each cycle is 28 days
Serum anti-drug antibody (ADA) incidence of Suvemcitug
Time frame: For about 6 cycles, each cycle is 28 days
Serum anti-drug antibody (ADA) duration of Suvemcitug
Time frame: For about 6 cycles, each cycle is 28 days
Serum anti-drug antibody (ADA) titer of Suvemcitug
Time frame: For about 6 cycles, each cycle is 28 days
Objective Response Rate (ORR) of all participants
Time frame: From the date when the first dose of Suvemcitug is administered until radiological progression, initiation of new anti-cancer therapy, death or withdrawal from study, whichever came first, assessed up to 18 months.
Duration of response (DoR) of all participants
Time frame: From the date when the first dose of Suvemcitug is administered until radiological progression, initiation of new anti-cancer therapy, death or withdrawal from study, whichever came first, assessed up to 18 months
Disease control rate (DCR) of all participants
Time frame: From the date when the first dose of Suvemcitug is administered until radiological progression, initiation of new anti-cancer therapy, death or withdrawal from study, whichever came first, assessed up to 18 months.
Progression free survival (PFS) of all participants
Time frame: From the date when the first dose of Suvemcitug is administered until radiological progression, initiation of new anti-cancer therapy, death or withdrawal from study, whichever came first, assessed up to 18 months.
Phase Ib: overall survival (OS)
Time frame: For about 18 months from the randomization of the last participant
Phase III: Adverse Events
Time frame: From signing informed consent form until 28 days after the last dose of study treatment, for about 18 months.
Phase III: quality of life - EORTC QLQ-C30
Time frame: Questionnaires will be collected from participants at baseline, and all efficacy evaluation visits, for up to 18 months
Phase III: quality of life - Euro Qol (EQ)-5D
Time frame: Questionnaires will be collected from participants at baseline, and all efficacy evaluation visits, for up to 18 months
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 22 Jan 2026.
- Individual participant dataSharing planned: Undecided
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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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Suvemcitug injection, trifluridine/tipiracil tablets in people with Refractory Metastatic Colorectal Cancer, run by Jiangsu Simcere Pharmaceutical Co., Ltd. at 6 sites 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 6 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Xueyan Li (+86-25-85566666, lixueyan1@zaiming.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase Ib: dose limiting toxicity (DLT) (time frame: At the end of Cycle 1 (each cycle is 28 days)). The study lists 4 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 22 Jan 2026.