Combined Hepatocellular-cholangiocarcinomaPhase 2NCT07243951
Phase II Clinical Study on the Efficacy and Safety of the Combination of Cadonilimab and Capecitabine in Adjuvant Therapy for Combined Hepatocellular Carcinoma and Intrahepatic Cholangiocarcinoma
A Phase 2 study testing Cadonilimab and Capecitabine in people with Combined Hepatocellular-cholangiocarcinoma and Liver Neoplasms, run by Shanghai Zhongshan Hospital.
Trial summary
Title: A Study of Cadonilimab Combined with Capecitabine After Surgery for Mixed Type Liver Cancer This is a phase II clinical trial. The main purpose of this study is to find out if using two drugs together, cadonilimab (an immunotherapy drug) and capecitabine (a chemotherapy drug), can help prevent the cancer from… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Combined Hepatocellular-cholangiocarcinoma, Liver Neoplasms
- What is being tested?
- Cadonilimab and Capecitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- 28 Nov 2025to 30 Jun 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
- Age 18-75 years.
- ECOG Performance Status ≤ 1.
- Pathologically confirmed combined hepatocellular carcinoma and intrahepatic cholangiocarcinoma (cHCC/CCA), with R0 resection and classified as Stage IB, Stage II, Stage IIIA, Stage IIIB, or Stage IA (G3) according to AJCC TNM Staging System (8th Edition, 2017).
- No extrahepatic metastasis.
- Post-operative Child-Pugh liver function class A; ECOG PS score: 0-1.
- For subjects with chronic HBV infection, HBV-DNA must be <500 IU/mL. HBsAg-positive patients must receive antiviral therapy according to the "Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2015)". HCV-RNA positive patients must receive antiviral therapy according to the "Guidelines for the Prevention and Treatment of Hepatitis C (2015)" and have normal liver function.
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- Adequate organ function, defined as follows:
- Hematological tests (no blood transfusion or use of hematopoietic growth factors within 14 days prior to screening):
- Hemoglobin (HB) ≥90 g/L
- Absolute neutrophil count (ANC) ≥1.5×10⁹/L
- Platelet count (PLT) ≥75×10⁹/L (2) Biochemical tests (no blood transfusion or blood products within 14 days prior to screening):
- 1) Albumin (ALB) ≥29 g/L 2) ALT and AST <2.5 × ULN 3) Total bilirubin (TBIL) ≤1.5 × ULN 4) Creatinine (Cr) ≤1.5 × ULN (3) International Normalized Ratio (INR) ≤2.3, or Prothrombin Time (PT) prolongation ≤6 seconds beyond the normal control range.
- 8. Female subjects of childbearing potential must have a negative serum or urine pregnancy test within 14 days before initiating study treatment and be willing to use effective and reliable methods of contraception during the trial and for one year after the last dose of the study drug.
- 9. Subjects voluntarily join the study, sign the informed consent form, have good compliance, and are willing to cooperate with follow-up.
- 10. No evidence of tumor recurrence or metastasis at baseline examination.
Who cannot join
- Pathological diagnosis of hepatocellular carcinoma (HCC), intrahepatic cholangiocarcinoma (ICC), or hilar cholangiocarcinoma.
- Incomplete tumor resection (non-R0), or postoperative pathology indicating a diagnosis other than cHCC/CCA.
- History of or concurrent other malignancies, except for cured localized tumors such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the prostate, carcinoma in situ of the cervix, carcinoma in situ of the breast, etc. Concurrent autoimmune diseases (e.g., autoimmune liver disease, systemic lupus erythematosus).
- Child-Pugh class B or C; history or presence of manifestations of hepatic decompensation (e.g., ascites, hepatic encephalopathy, upper gastrointestinal bleeding, etc.).
- Known hereditary or acquired bleeding or thrombotic tendencies, such as hemophilia.
- Presence of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 2 months prior to study participation.
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- Myocardial ischemia of grade II or above, myocardial infarction, or poorly controlled arrhythmias (including QTcF interval ≥450 ms for males or ≥470 ms for females; QTc interval calculated by Fridericia's formula). Cardiac insufficiency of NYHA Class III-IV or left ventricular ejection fraction (LVEF) <50% on echocardiography.
- Severe cardiopulmonary dysfunction or severe renal insufficiency.
- History of thrombotic/embolic events within the past 6 months, such as cerebrovascular events (including transient ischemic attack) or pulmonary embolism.
- Inability to swallow, chronic diarrhea, or intestinal obstruction that significantly affects drug administration and absorption.
- Untreated active hepatitis (Hepatitis B: HBsAg positive with abnormal liver function and HBV-DNA ≥500 IU/mL; Hepatitis C: HCV-RNA positive with abnormal liver function).
- Human Immunodeficiency Virus (HIV) infection.
- Active infection or unexplained fever (>38.5°C) occurring during the screening period or before the first dose.
- Receipt of any vaccine within 30 days prior to enrollment. Planned or prior history of allogeneic organ or bone marrow transplantation, including liver transplantation.
- History or current presence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, severely impaired pulmonary function, or other conditions that may interfere with the detection and management of suspected drug-related pulmonary toxicity.
- Hypertension that cannot be well controlled with antihypertensive medication (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg).
- Coagulation dysfunction (PT >16s, APTT >43s, TT >21s, Fibrinogen <2 g/L), bleeding tendency, or ongoing thrombolytic or anticoagulant therapy.
- Significant clinically significant bleeding symptoms or definite bleeding tendency within 3 months before the first dose, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, baseline fecal occult blood ++ or higher, or presence of vasculitis.
- Active, known, or suspected autoimmune disease (including but not limited to uveitis, enteritis, hepatitis, hypophysitis, nephritis, vasculitis, hyperthyroidism, hypothyroidism, asthma requiring bronchodilators, etc.). Subjects in a stable state not requiring systemic immunosuppressive therapy are allowed.
- Requirement for systemic treatment with corticosteroids (>10 mg/day prednisone equivalent) or other immunosuppressants within 14 days prior to study drug administration. Inhaled or topical steroids and adrenal replacement therapy at doses >10 mg/day prednisone equivalent are permitted in the absence of active autoimmune disease.
- Prior treatment with other PD-1 antibodies or other immunotherapy targeting PD-1/PD-L1. Known history of severe allergy to any monoclonal antibody, anti-angiogenic targeted drugs, platinum agents, fluorouracil, or any component of the study drugs.
- Requirement for long-term anticoagulation therapy with warfarin or heparin; requirement for long-term antiplatelet therapy (aspirin ≥300 mg/day or clopidogrel ≥75 mg/day).
- Known history of psychotropic drug abuse or drug addiction. Pregnant or lactating women.
- Any other factor considered by the investigator to be likely to lead to premature termination of the study, such as other severe diseases, significant laboratory abnormalities, or accompanying familial or social factors that may affect the subject's safety or the collection of trial data and samples.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Title: A Study of Cadonilimab Combined with Capecitabine After Surgery for Mixed Type Liver Cancer
This is a phase II clinical trial. The main purpose of this study is to find out if using two drugs together, cadonilimab (an immunotherapy drug) and capecitabine (a chemotherapy drug), can help prevent the cancer from coming back after surgery in patients with a specific type of liver cancer called combined hepatocellular-cholangiocarcinoma (cHCC/CCA). This type of liver cancer is rare and has a high chance of returning even after successful surgery.
Read more
The study will involve about 75 patients who have had their tumor completely removed but are still at medium to high risk of the cancer returning. All participants in the study will receive the same combination of drugs. Cadonilimab is given through a vein every three weeks. Capecitabine is taken as a pill twice a day for two weeks, followed by one week off. This cycle repeats for up to 8 cycles (about 6 months), or until the cancer comes back or side effects become too severe.
Researchers will primarily measure how long patients live without the cancer returning (Recurrence-Free Survival). They will also track how long patients live overall (Overall Survival), and carefully record any side effects to understand the safety of this treatment combination.
The study hypothesis is that this combination therapy will significantly prolong RFS compared to historical outcomes with surgery alone, while demonstrating acceptable safety.
Read the detailed description
Protocol Title: Phase II Clinical Trial on the Efficacy and Safety of the Combination of Cadonilimab and Capecitabine in Adjuvant Therapy for Combined Hepatocellular Carcinoma and Intrahepatic Cholangiocarcinoma
Study Background and Rationale:
Combined hepatocellular-cholangiocarcinoma (cHCC/CCA) represents a rare primary liver malignancy exhibiting dual hepatocellular and cholangiocellular differentiation, accounting for approximately 0.4%-14.2% of all liver cancers. Despite R0 resection, postoperative recurrence rates remain exceedingly high (78.6% in reported series), with median overall survival of only 9-18 months. Currently, no standardized adjuvant therapy exists for cHCC/CCA following resection. This study investigates a novel combination strategy utilizing cadonilimab (a bispecific antibody targeting both PD-1 and CTLA-4) with capecitabine chemotherapy to address this unmet medical need by potentially enhancing antitumor immunity and eliminating micrometastatic disease in the postoperative setting.
Study Design:
This is a prospective, single-arm, open-label, multi-center phase II clinical study conducted under investigator initiation.
Intervention Protocol:
- Cadonilimab (AK104): 10 mg/kg administered via intravenous infusion over 60-120 minutes (minimum 60 minutes) on Day 1 of each 21-day cycle.
- Capecitabine: 2500 mg/m²/day administered orally in two divided doses within 30 minutes after morning and evening meals for 14 consecutive days followed by 7 days rest, constituting one 21-day cycle.
- Treatment Duration: Treatment continues for 8 cycles (24 weeks) unless terminated earlier due to: radiologically confirmed disease recurrence per RECIST 1.1, unacceptable toxicity, withdrawal of consent, or investigator decision.
Study Assessments:
- Tumor Evaluations: Radiological assessments (CT/MRI) performed every 12 weeks (4 cycles) during treatment. Post-treatment, patients without recurrence undergo imaging every 12 weeks until 24 months, followed by ultrasonography every 3 months with additional MRI/CT as clinically indicated.
- Safety Monitoring: Comprehensive safety assessments including adverse event monitoring (NCI-CTCAE v5.0), laboratory evaluations (hematology, biochemistry, coagulation, thyroid function), vital signs, physical examinations, and ECG performed at each cycle.
- Follow-up Schedule: Safety follow-up continues for 90 days after last cadonilimab dose or 30 days after last capecitabine dose. Survival follow-up conducted every 3 months (±14 days) via telephone or clinic visit after treatment completion.
Statistical Considerations:
The sample size of 75 patients was calculated to detect an improvement in median RFS from 12.2 months (historical control) to 18 months (HR=0.678) with 80% power at two-sided alpha=0.05, accounting for 5% drop-out rate. Efficacy analyses will utilize the Full Analysis Set (FAS) with Kaplan-Meier methodology for estimating RFS and OS, supplemented with 95% confidence intervals using Clopper-Pearson method.
- Being tested
- Cadonilimab, Capecitabine
- Keywords
- Cadonilimab, Capecitabine, Phase II Clinical Trial, Bispecific Antibody, PD-1, CTLA-4, Recurrence-Free Survival, Immunotherapy, Adjuvant Therapy
- Medical subject headings
- Liver Neoplasms, Diabetes Mellitus, Insulin-Dependent, 12
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CadonilimabDrug
Cadonilimab is a bispecific monoclonal antibody targeting both PD-1 and CTLA-4. It will be administered intravenously at a dose of 10 mg/kg over 60-120 minutes (no less than 60 minutes) on Day 1 of each 3-week cycle.
CapecitabineDrug
Capecitabine is an oral chemotherapeutic prodrug that is converted to 5-fluorouracil in the body. The dose is 2500 mg/m² per day, administered orally in two divided doses (morning and evening) within 30 minutes after a meal. It is given for 2 weeks followed by a 1-week rest, constituting one 3-week cycle.
| Study group | Role | What they receive |
|---|---|---|
| Cadonilimab + Capecitabine Combination Therapy | Experimental | This arm receives the combination therapy of Cadonilimab (intravenous infusion, 10 mg/kg, once every 3 weeks) and Capecitabine (oral, 2500 mg/m²/day administered in two divided doses, on a schedule of 2 weeks of treatment followed by 1 week of rest) for up to 8 cycles (24 weeks), or until disease recurrence, unacceptable toxicity, or other treatment discontinuation criteria are met. Receives: Drug: Cadonilimab; Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence-Free Survival (RFS)
The length of time after primary treatment for cancer ends that the patient survives without any signs or symptoms of that cancer. Tumor recurrence or metastasis will be determined based on radiological imaging (CT or MRI) and evaluated according to RECIST 1.1 criteria.
Measured: From the start of treatment until the date of first documented recurrence, metastasis, or death from any cause.ssessed regularly every 12 weeks (every 4 cycles) during treatment, then every 12 weeks until 24 months after treatment completion.
Secondary outcomes (2)
Overall Survival (OS)
The length of time from the start of treatment that patients are still alive. It is a direct measure of the clinical benefit of the treatment.
Measured: From the start of treatment until the date of death from any cause, assessed every 3 months (±14 days) until 24 months after treatment completion.
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
The safety and tolerability of the combination therapy will be assessed by monitoring the type, frequency, severity, and relationship to study drugs of all adverse events and serious adverse events. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0.
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start28 Nov 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Combined Hepatocellular-cholangiocarcinomaStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07243951
- Sponsor's protocol ID
- B2025-381R
- Status last verified
- Nov 2025
- First submitted
- 17 Nov 2025
- Last updated
- 24 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Clinical Study on the Efficacy and Safety of the Combination of Cadonilimab and Capecitabine in Adjuvant Therapy for Combined Hepatocellular Carcinoma and Intrahepatic Cholangiocarcinoma
- ClinicalTrials.gov ID
- NCT07243951
- Acronym / sponsor ID
- B2025-381R
- Keywords
- Cadonilimab, Capecitabine, Phase II Clinical Trial, Bispecific Antibody, PD-1, CTLA-4, Recurrence-Free Survival, Immunotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 28 Nov 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 24 Nov 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.
Title: A Study of Cadonilimab Combined with Capecitabine After Surgery for Mixed Type Liver Cancer
This is a phase II clinical trial. The main purpose of this study is to find out if using two drugs together, cadonilimab (an immunotherapy drug) and capecitabine (a chemotherapy drug), can help prevent the cancer from coming back after surgery in patients with a specific type of liver cancer called combined hepatocellular-cholangiocarcinoma (cHCC/CCA). This type of liver cancer is rare and has a high chance of returning even after successful surgery.
The study will involve about 75 patients who have had their tumor completely removed but are still at medium to high risk of the cancer returning. All participants in the study will receive the same combination of drugs. Cadonilimab is given through a vein every three weeks. Capecitabine is taken as a pill twice a day for two weeks, followed by one week off. This cycle repeats for up to 8 cycles (about 6 months), or until the cancer comes back or side effects become too severe.
Researchers will primarily measure how long patients live without the cancer returning (Recurrence-Free Survival). They will also track how long patients live overall (Overall Survival), and carefully record any side effects to understand the safety of this treatment combination.
The study hypothesis is that this combination therapy will significantly prolong RFS compared to historical outcomes with surgery alone, while demonstrating acceptable safety.
Detailed description
Protocol Title: Phase II Clinical Trial on the Efficacy and Safety of the Combination of Cadonilimab and Capecitabine in Adjuvant Therapy for Combined Hepatocellular Carcinoma and Intrahepatic Cholangiocarcinoma
Study Background and Rationale:
Combined hepatocellular-cholangiocarcinoma (cHCC/CCA) represents a rare primary liver malignancy exhibiting dual hepatocellular and cholangiocellular differentiation, accounting for approximately 0.4%-14.2% of all liver cancers. Despite R0 resection, postoperative recurrence rates remain exceedingly high (78.6% in reported series), with median overall survival of only 9-18 months. Currently, no standardized adjuvant therapy exists for cHCC/CCA following resection. This study investigates a novel combination strategy utilizing cadonilimab (a bispecific antibody targeting both PD-1 and CTLA-4) with capecitabine chemotherapy to address this unmet medical need by potentially enhancing antitumor immunity and eliminating micrometastatic disease in the postoperative setting.
Study Design:
This is a prospective, single-arm, open-label, multi-center phase II clinical study conducted under investigator initiation.
Intervention Protocol:
- Cadonilimab (AK104): 10 mg/kg administered via intravenous infusion over 60-120 minutes (minimum 60 minutes) on Day 1 of each 21-day cycle.
- Capecitabine: 2500 mg/m²/day administered orally in two divided doses within 30 minutes after morning and evening meals for 14 consecutive days followed by 7 days rest, constituting one 21-day cycle.
- Treatment Duration: Treatment continues for 8 cycles (24 weeks) unless terminated earlier due to: radiologically confirmed disease recurrence per RECIST 1.1, unacceptable toxicity, withdrawal of consent, or investigator decision.
Study Assessments:
- Tumor Evaluations: Radiological assessments (CT/MRI) performed every 12 weeks (4 cycles) during treatment. Post-treatment, patients without recurrence undergo imaging every 12 weeks until 24 months, followed by ultrasonography every 3 months with additional MRI/CT as clinically indicated.
- Safety Monitoring: Comprehensive safety assessments including adverse event monitoring (NCI-CTCAE v5.0), laboratory evaluations (hematology, biochemistry, coagulation, thyroid function), vital signs, physical examinations, and ECG performed at each cycle.
- Follow-up Schedule: Safety follow-up continues for 90 days after last cadonilimab dose or 30 days after last capecitabine dose. Survival follow-up conducted every 3 months (±14 days) via telephone or clinic visit after treatment completion.
Statistical Considerations:
The sample size of 75 patients was calculated to detect an improvement in median RFS from 12.2 months (historical control) to 18 months (HR=0.678) with 80% power at two-sided alpha=0.05, accounting for 5% drop-out rate. Efficacy analyses will utilize the Full Analysis Set (FAS) with Kaplan-Meier methodology for estimating RFS and OS, supplemented with 95% confidence intervals using Clopper-Pearson method.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cadonilimab + Capecitabine Combination Therapy | Experimental | Drug: Cadonilimab, Drug: CapecitabineThis arm receives the combination therapy of Cadonilimab (intravenous infusion, 10 mg/kg, once every 3 weeks) and Capecitabine (oral, 2500 mg/m²/day administered in two divided doses, on a schedule of 2 weeks of treatment followed by 1 week of rest) for up to 8 cycles (24 weeks), or until disease recurrence, unacceptable toxicity, or other treatment discontinuation criteria are met. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Age 18-75 years.
- ECOG Performance Status ≤ 1.
- Pathologically confirmed combined hepatocellular carcinoma and intrahepatic cholangiocarcinoma (cHCC/CCA), with R0 resection and classified as Stage IB, Stage II, Stage IIIA, Stage IIIB, or Stage IA (G3) according to AJCC TNM Staging System (8th Edition, 2017).
- No extrahepatic metastasis.
- Post-operative Child-Pugh liver function class A; ECOG PS score: 0-1.
Key exclusion criteria (24 listed)
- Pathological diagnosis of hepatocellular carcinoma (HCC), intrahepatic cholangiocarcinoma (ICC), or hilar cholangiocarcinoma.
- Incomplete tumor resection (non-R0), or postoperative pathology indicating a diagnosis other than cHCC/CCA.
- History of or concurrent other malignancies, except for cured localized tumors such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the prostate, carcinoma in situ of the cervix, carcinoma in situ of the breast, etc. Concurrent autoimmune diseases (e.g., autoimmune liver disease, systemic lupus erythematosus).
- Child-Pugh class B or C; history or presence of manifestations of hepatic decompensation (e.g., ascites, hepatic encephalopathy, upper gastrointestinal bleeding, etc.).
- Known hereditary or acquired bleeding or thrombotic tendencies, such as hemophilia.
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 |
|---|---|---|
| CadonilimabCadonilimab is a bispecific monoclonal antibody targeting both PD-1 and CTLA-4. It will be administered intravenously at a dose of 10 mg/kg over 60-120 minutes (no less than 60 minutes) on Day 1 of each 3-week cycle. | Drug | Cadonilimab + Capecitabine Combination Therapy |
| CapecitabineCapecitabine is an oral chemotherapeutic prodrug that is converted to 5-fluorouracil in the body. The dose is 2500 mg/m² per day, administered orally in two divided doses (morning and evening) within 30 minutes after a meal. It is given for 2 weeks followed by a 1-week rest, constituting one 3-week cycle. | Drug | Cadonilimab + Capecitabine Combination Therapy |
Primary outcome
Recurrence-Free Survival (RFS)
Time frame: From the start of treatment until the date of first documented recurrence, metastasis, or death from any cause.ssessed regularly every 12 weeks (every 4 cycles) during treatment, then every 12 weeks until 24 months after treatment completion.
The length of time after primary treatment for cancer ends that the patient survives without any signs or symptoms of that cancer. Tumor recurrence or metastasis will be determined based on radiological imaging (CT or MRI) and evaluated according to RECIST 1.1 criteria.
2 secondary outcomes
Overall Survival (OS)
Time frame: From the start of treatment until the date of death from any cause, assessed every 3 months (±14 days) until 24 months after treatment completion.
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: up to 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 24 Nov 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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cadonilimab and Capecitabine in people with Combined Hepatocellular-cholangiocarcinoma and Liver Neoplasms, run by Shanghai Zhongshan Hospital.
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 15 inclusion and 24 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 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Qiang GAO, Doctor (086-021-64041990-2047, gaoqiang@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence-Free Survival (RFS) (time frame: From the start of treatment until the date of first documented recurrence, metastasis, or death from any cause.ssessed regularly every 12 weeks (every 4 cycles) during treatment, then every 12 weeks until 24 months after treatment completion.). 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 24 Nov 2025.