Colorectal CancerPhase 3NCT06566755
Cadonilimab (AK104) Combined With Chemotherapy and Bevacizumab as First-line Treatment for RAS Mutated or Right Sided-metastatic MSS Colorectal Cancer
A Phase 3 study testing Cadonilimab (AK104) combined with chemotherapy and bevacizumab in people with Colorectal Cancer, run by Caigang Liu at 1 site in China.
Trial summary
The purpose of this study is to assess the efficacy and safety of Cadonilimab (AK104) combined with chemotherapy and bevacizumab as first-line treatment for patients with RAS mutated or right sided-metastatic MSS colorectal cancer Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Cadonilimab (AK104) combined with chemotherapy and bevacizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2024to 1 Feb 2027
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to understand and voluntarily sign a written informed consent form, which must be signed before the designated research procedures required for the study are carried out.
- Age at the time of signing the Informed Consent Form (ICF) is ≥ 18 years old and ≤ 75 years old, both male and female.
- The Eastern Cancer Collaborative Organization (ECOG) has a physical fitness score of 0 or 1.
- The expected survival period is ≥ 3 months.
- Recurrent or incurable metastatic colorectal adenocarcinoma confirmed by Histopathology.(UICC/AJCC colorectal TNM stage System (8th edition 2017))
- Genetic testing revealed RAS (including KRAS and NRAS) mutations, or primary sites located in the right half of the colon (including cecum, rising Colon and proximal 2/3 transverse colon).
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- Did not receive systemic treatment for recurrent or metastatic disease.
- According to the RECIST v1.1 standard, there is at least one measurable tumor lesion. Agree to provide archived or freshly obtained tumor tissue samples (formalin fixed paraffin embedded [FFPE] tissue wax blocks or at least 5 unstained tumor tissue slice samples) to confirm PD-L1 expression.
- The time interval between the end of adjuvant therapy was >12 months.
- Having good organ function:
- Blood routine examination (no blood components or cell growth factors were used to support treatment within the first 7 days of randomization):
- Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L;
- Platelet count ≥ 100 × 10^9/L;
- Hemoglobin ≥ 9.0g/dL.
- Kidney:
- Creatinine<1.5 × ULN, or creatinine clearance rate (CrCl) calculated value ≥ 50mL/min;
- The Cockcroft Fault formula will be used to calculate CrCl: CrCL (mL/min)={(140 age) × Body weight (kg) × F} /(SCr (mg/dL) × 72) Among them: F=1 for males and F=0.85 for females; SCr=serum creatinine. Urinary protein<2+or 24-hour urine protein quantification<1.0g.
- Liver:
- Serum total bilirubin (TBiL) ≤ 1.5 × ULN; AST and ALT ≤ 2.5 × ULN (AST and ALT ≤ 5 for subjects with liver metastasis) × ULN, but not accompanied by elevated bilirubin);
- Coagulation function:
- International standardized ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN
- Thyroid function: thyroid stimulating hormone (TSH) ≤ ULN; If abnormal, T3 and T4 levels should be investigated, and normal levels Can be selected
- Female subjects with fertility must undergo a serum pregnancy test within 72 hours before the first medication, and the result should be negative. If a female subject with fertility engages in sexual activity with an unsterilized male partner, the subject must adopt an acceptable contraceptive method starting from screening and must agree to continue using the contraceptive method for 120 days after the last dose of the study drug; Periodic abstinence and safe period contraception are unacceptable contraceptive methods. Whether to stop contraception after this time point should be discussed with researchers.
- Women with fertility refer to those who have not undergone surgical sterilization (i.e. bilateral fallopian tube ligation, bilateral oophorectomy, or total hysterectomy) or those who have not undergone menopause (defined as those who have ceased menstruation for at least 12 consecutive months without alternative medical reasons, and whose serum follicle stimulating hormone levels are within the laboratory reference range of postmenopausal women);
- An efficient contraceptive method refers to a contraceptive method with a low failure rate (such as less than 1% per year) under continuous and correct use. Not all contraceptive methods are efficient. In addition to barrier contraception, female subjects with fertility can also use hormonal contraception (such as birth control pills), intrauterine device contraception, etc. to ensure that pregnancy does not occur.
Who cannot join
- Previously received treatment with PD-1 monoclonal antibody, PD-L1 monoclonal antibody, or CTLA-4 monoclonal antibody.
- The tumor tissue was found to be dMMR or MSI-H
- Received palliative local treatment within the first 2 weeks of randomization; Received systemic non-specific immunomodulatory therapy (such as interleukin, interferon, thymosin, etc.) within the first 2 weeks of randomization; In the first 2 weeks of randomization, they received Chinese herbal medicine or traditional Chinese patent medicines and simple preparations with anti-tumor indications.
- Currently participating in another clinical study, unless it is an observational, non-interventional clinical study, or a follow-up period of an intervention study.
- Had or was currently present with other malignancies within the first 3 years of randomization. The following conditions can be included: cured uterus cervical carcinoma in situ, non-melanoma skin cancer and superficial bladder tumors [Ta (non-invasive tumor), Tis (cancer in situ) and T1 (tumor infiltrating basal membrane)].
- Have active or untreated brain metastases, meningeal metastases, spinal cord compression, or leptomeningeal diseases. However, participants who meet the following requirements and have measurable lesions outside the central nervous system are allowed to be enrolled: asymptomatic after treatment, imageologically stable for at least 4 weeks before the start of study treatment (if there are no new or expanded brain metastases), and have stopped systemic glucocorticoid and anticonvulsant drug treatment for at least 2 weeks.
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- Have clinical symptoms of pleural effusion, pericardial effusion, or pleural/ascites that require frequent drainage (≥ once per month).
- Active autoimmune diseases that require systematic treatment within the first 2 years of randomization, or autoimmune diseases that the researcher determines may recur or plan treatment. Except for the following:
- Skin diseases that do not require systematic treatment (such as vitiligo, alopecia, psoriasis, or eczema);
- Hypothyroidism caused by autoimmune thyroiditis requires only stable doses of hormone replacement therapy;
- Type I diabetes requiring only a stable dose of insulin replacement therapy;
- Childhood asthma has completely relieved, and no intervention is required in adulthood;
- Researchers have determined that the disease will not recur without external triggering factors.
- Any of the following cardiovascular or cerebrovascular diseases or risk factors:
- Myocardial infarction, unstable angina, cerebrovascular accident, transient ischemic attack, acute or persistent myocardial ischemia, symptomatic heart failure (grade 2 or above according to the New York Heart Association functional classification), symptomatic or poorly controlled arrhythmia, or any arterial thromboembolism event occurred within the first 6 months of randomization.
- A history of deep vein thrombosis, pulmonary embolism, or other severe thromboembolism within the first 3 months of randomization.
- Have major vascular diseases such as aortic aneurysm, aortic dissection aneurysm, internal carotid artery stenosis that may endanger life or require surgery within 6 months.
- Uncontrolled hypertension (systolic blood pressure ≥150mmHg or diastolic blood pressure ≥100mmHg after standard antihypertensive therapy)
- Previous history of myocarditis and cardiomyopathy.
- Left ventricular ejection fraction (LVEF)<50%.
- Toxicity that has not been alleviated by previous anti-tumor therapy is defined as failure to regress to the National Cancer Institute Adverse Event General Terminology Standard ((NCICTCAE v5.0) level 0 or 1, or the level specified in the inclusion/exclusion criteria, except for hair loss/pigmentation, ≥ Level 2 peripheral nerve disease).
- The presence of interstitial lung disease or non infectious pneumonia is known, and the disease is currently symptomatic or requires systemic glucocorticoid treatment in the past. Researchers have determined that it may affect the toxicity assessment or management related to the study treatment.
- Active pulmonary tuberculosis is known to exist. Subjects suspected of active pulmonary tuberculosis need to undergo chest X-ray examination, sputum examination, and elimination through clinical symptoms and signs.
- Received systemic anti infective therapy (excluding antiviral therapy for hepatitis B or C) within the first 2 weeks of randomization.
- Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
- Imaging (CT or MRI) shows that the tumor has invaded the large blood vessels or is not clearly delimited from the blood vessels.
- Have clinical active diverticulitis, abdominal abscess, and gastrointestinal obstruction, unhealed wounds, ulcers, or fractures.
- Clinically significant bleeding symptoms or bleeding tendencies within the first month of randomization, such as gastrointestinal bleeding, active hemoptysis, or bleeding, clotting disease are taking warfarin, aspirin, or other antiplatelet drugs (except maintenance doses: aspirin ≤100mg/ day, clopidogrel ≤75mg/ day), or regardless of severity，Subjects with any signs of bleeding or medical history that the investigator has determined are not suitable for enrollment.
- Received major surgical treatment, open biopsy, or significant traumatic injury (except needle biopsy or gastroenteroscopic tissue biopsy) within the first 28 days of randomization.
- Individuals with a known history of immune deficiency or HIV testing positive,Known active syphilis infection.
- Subjects who require systemic treatment with glucocorticoids (>10mg/day prednisone or equivalent dose) or other immunosuppressive drugs within the first 14 days of randomization. Except for the following:
- If there is no active autoimmune disease, it is allowed to use inhaled, ophthalmic, or topical corticosteroids or other corticosteroids with a dose ≤ 10mg/day of prednisone or equivalent.
- The dosage of systemic glucocorticoids in physiological doses is ≤ 10mg/day of prednisone or equivalent doses of other glucocorticoids.
- Glucocorticoids are used as pretreatment for infusion related reactions or allergic reactions (such as medication before CT examination).
- For untreated active hepatitis B subjects (HBsAg positive and HBV-DNA more than 1000 copies/ml [200IU/ml] or higher than the lower detection limit), patients with hepatitis B are required to receive anti hepatitis B virus treatment during the study treatment period; Active hepatitis C subjects (with positive HCV antibodies and HCV-RNA levels above the detection limit).
- Received live vaccine within 30 days prior to randomization, or planned to receive live vaccine during the study period.
- Subjects who have a known history of allergic or hypersensitive reactions to Cadonilimab, bevacizumab, capecitabine, oxaliplatin or any of their components. A history of severe hypersensitivity to other monoclonal antibodies is known.
- In the judgment of the investigator, there is a concomitant disease that seriously endangers the safety of the subjects or interferes with the completion of the study, or subjects who were not suitable for inclusion for other reasons.
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, 1 recruiting
- Recruiting
Shengjing Hospital of China Medical University
Shenyang, Liaoning
Caigang Liu, MD, 86+18940256668, liucg@sj-hospital.org
About this study
Official title: Study of Cadonilimab(AK104) Combined With Chemotherapy and Bevacizumab as First-line Treatment for RAS Mutated or Right Sided-metastatic MSS Colorectal Cancer
The purpose of this study is to assess the efficacy and safety of Cadonilimab (AK104) combined with chemotherapy and bevacizumab as first-line treatment for patients with RAS mutated or right sided-metastatic MSS colorectal cancer
- Conditions
- Colorectal Cancer
- Being tested
- Cadonilimab (AK104) combined with chemotherapy and bevacizumab
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cadonilimab (AK104) combined with chemotherapy and bevacizumabDrug
Participants receive Cadonilimab PLUS chemotherapy and bevacizumab of each 21-day cycle.
Treatment period (4-8 cycles)：
- Cadonilimab: 10mg/kg, intravenous infusion, D1, Q3W;
- CapeOx chemotherapy regimen Q3W+ bevacizumab, Q3W: oxaliplatin: 130 mg/m2 intravenous infusion, D1, Q3W; capecitabine: 850 mg/m2 orally, D1-14, Q3W, twice daily; bevacizumab injection: 7.5mg/kg, IV, D1, Q3W. Maintenance treatment period：
- Cadonilimab: 10mg/kg, administered D1, Q3W;
- capecitabine: 1000 mg/m2 orally, D1-14, Q3W, twice daily;
- bevacizumab injection: 7.5mg/kg, IV, D1, Q3W.
| Study group | Role | What they receive |
|---|---|---|
| Cadonilimab (AK104) combined with chemotherapy and bevacizumab | Experimental | Participants receive Cadonilimab PLUS chemotherapy and bevacizumab of each 21-day cycle.
Treatment period (4-8 cycles)：
* Cadonilimab: 10mg/kg, intravenous infusion, D1, Q3W;
* CapeOx chemotherapy regimen Q3W+ bevacizumab, Q3W:
oxaliplatin: 130 mg/m2 intravenous infusion, D1, Q3W capecitabine: 850 mg/m2 orally, D1-14, Q3W, twice daily; bevacizumab injection: 7.5mg/kg, IV, D1, Q3W. Maintenance treatment period：
* Cadonilimab: 10mg/kg, administered D1, Q3W;
* capecitabine: 1000 mg/m2 orally, D1-14, Q3W, twice daily;
* bevacizumab injection: 7.5mg/kg, IV, D1, Q3W. Receives: Drug: Cadonilimab (AK104) combined with chemotherapy and bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Investigator
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥ 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions was also considered PD. The PFS per RECIST 1.1 as assessed by Investigator will be presented.
Measured: Up to approximately 1 year
Secondary outcomes (7)
Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by Investigator
ORR is defined as the percentage of the participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters).
Measured: Up to approximately 1years
Disease control Rate (DCR) Per RECIST 1.1 as Assessed by Investigator
DCR is the rate of CR,PR plus SD
Measured: Up to approximately 1 year
Duration of Response (DoR) Per RECIST 1.1 as Assessed by Investigator
For participants who demonstrate CR or PR, DOR is defined as the time from first documented evidence of CR or PR until disease progression or death. The DOR per RECIST 1.1 as assessed by Investigator will be presented.
Measured: Up to approximately 1 year
Time to response（TTR）
The time from randomization to the first CR or PR recorded
Measured: Up to approximately 6 months
Overall Survival (OS)
OS is defined as the time from randomization to death due to any cause.
Measured: From randomization through 90 days after last dose of study treatment
Number of Participants Who Experience an Adverse Event (AE)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be presented.
Measured: From randomization through 30 days after last dose of study treatment
Number of Participants Who Experience a Serious AE (SAE)
An SAE is defined as any untoward medical occurrence that, at any dose: a.) Results in death; b.) Is life-threatening; c.) Requires inpatient hospitalization or prolongation of existing hospitalization; d.) Results in persistent or significant disability/incapacity; e.) Is a congenital anomaly/birth defect; f.) Other important medical events; h.) Is a new cancer (that is not a condition of the study) or i.) Is associated with an overdose. The number of participants who experience an SAE will be presented.
Measured: From randomization through 90 days after last dose of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2024
- Study start1 Feb 2024
- Primary completion1 Feb 2026 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Caigang Liu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Caigang Liu, Shengjing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06566755
- Sponsor's protocol ID
- AK104-IIT-C-M-0020
- Status last verified
- Aug 2024
- First submitted
- 21 Aug 2024
- Last updated
- 22 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Cadonilimab(AK104) Combined With Chemotherapy and Bevacizumab as First-line Treatment for RAS Mutated or Right Sided-metastatic MSS Colorectal Cancer
- ClinicalTrials.gov ID
- NCT06566755
- Acronym / sponsor ID
- AK104-IIT-C-M-0020
- Conditions
- Colorectal Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Caigang LiuUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 22 Aug 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 purpose of this study is to assess the efficacy and safety of Cadonilimab (AK104) combined with chemotherapy and bevacizumab as first-line treatment for patients with RAS mutated or right sided-metastatic MSS colorectal cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cadonilimab (AK104) combined with chemotherapy and bevacizumab | Experimental | Drug: Cadonilimab (AK104) combined with chemotherapy and bevacizumabParticipants receive Cadonilimab PLUS chemotherapy and bevacizumab of each 21-day cycle. Treatment period (4-8 cycles)： * Cadonilimab: 10mg/kg, intravenous infusion, D1, Q3W; * CapeOx chemotherapy regimen Q3W+ bevacizumab, Q3W: oxaliplatin: 130 mg/m2 intravenous infusion, D1, Q3W capecitabine: 850 mg/m2 orally, D1-14, Q3W, twice daily; bevacizumab injection: 7.5mg/kg, IV, D1, Q3W. Maintenance treatment period： * Cadonilimab: 10mg/kg, administered D1, Q3W; * capecitabine: 1000 mg/m2 orally, D1-14, Q3W, twice daily; * bevacizumab injection: 7.5mg/kg, IV, D1, Q3W. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Able to understand and voluntarily sign a written informed consent form, which must be signed before the designated research procedures required for the study are carried out.
- Age at the time of signing the Informed Consent Form (ICF) is ≥ 18 years old and ≤ 75 years old, both male and female.
- The Eastern Cancer Collaborative Organization (ECOG) has a physical fitness score of 0 or 1.
- The expected survival period is ≥ 3 months.
- Recurrent or incurable metastatic colorectal adenocarcinoma confirmed by Histopathology.(UICC/AJCC colorectal TNM stage System (8th edition 2017))
Key exclusion criteria (38 listed)
- Previously received treatment with PD-1 monoclonal antibody, PD-L1 monoclonal antibody, or CTLA-4 monoclonal antibody.
- The tumor tissue was found to be dMMR or MSI-H
- Received palliative local treatment within the first 2 weeks of randomization; Received systemic non-specific immunomodulatory therapy (such as interleukin, interferon, thymosin, etc.) within the first 2 weeks of randomization; In the first 2 weeks of randomization, they received Chinese herbal medicine or traditional Chinese patent medicines and simple preparations with anti-tumor indications.
- Currently participating in another clinical study, unless it is an observational, non-interventional clinical study, or a follow-up period of an intervention study.
- Had or was currently present with other malignancies within the first 3 years of randomization. The following conditions can be included: cured uterus cervical carcinoma in situ, non-melanoma skin cancer and superficial bladder tumors [Ta (non-invasive tumor), Tis (cancer in situ) and T1 (tumor infiltrating basal membrane)].
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 |
|---|---|---|
| Cadonilimab (AK104) combined with chemotherapy and bevacizumabParticipants receive Cadonilimab PLUS chemotherapy and bevacizumab of each 21-day cycle. Treatment period (4-8 cycles)： * Cadonilimab: 10mg/kg, intravenous infusion, D1, Q3W; * CapeOx chemotherapy regimen Q3W+ bevacizumab, Q3W: oxaliplatin: 130 mg/m2 intravenous infusion, D1, Q3W; capecitabine: 850 mg/m2 orally, D1-14, Q3W, twice daily; bevacizumab injection: 7.5mg/kg, IV, D1, Q3W. Maintenance treatment period： * Cadonilimab: 10mg/kg, administered D1, Q3W; * capecitabine: 1000 mg/m2 orally, D1-14, Q3W, twice daily; * bevacizumab injection: 7.5mg/kg, IV, D1, Q3W. | Drug | Cadonilimab (AK104) combined with chemotherapy and bevacizumab |
Primary outcome
Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Investigator
Time frame: Up to approximately 1 year
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥ 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions was also considered PD. The PFS per RECIST 1.1 as assessed by Investigator will be presented.
7 secondary outcomes
Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by Investigator
Time frame: Up to approximately 1years
Disease control Rate (DCR) Per RECIST 1.1 as Assessed by Investigator
Time frame: Up to approximately 1 year
Duration of Response (DoR) Per RECIST 1.1 as Assessed by Investigator
Time frame: Up to approximately 1 year
Time to response（TTR）
Time frame: Up to approximately 6 months
Overall Survival (OS)
Time frame: From randomization through 90 days after last dose of study treatment
Number of Participants Who Experience an Adverse Event (AE)
Time frame: From randomization through 30 days after last dose of study treatment
Number of Participants Who Experience a Serious AE (SAE)
Time frame: From randomization through 90 days after last dose of study treatment
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 Aug 2024.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cadonilimab (AK104) combined with chemotherapy and bevacizumab in people with Colorectal Cancer, run by Caigang Liu 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 25 inclusion and 38 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 Aug 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 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 Nan Niu, MD (86+18940256668, niunannancy@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Investigator (time frame: Up to approximately 1 year). 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 Aug 2024.