Cholangiocarcinoma ResectablePhase 2NEOLANGIONCT06569225
Gemcitabine/Cisplatin/Nab-Paclitaxel and Rilvegostomig in Resectable iCCA
A Phase 2 study testing Gemcitabine/Cisplatin/Nab-Paclitaxel and Rilvegostomig in people with Cholangiocarcinoma Resectable, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Biliary tract cancer is a highly aggressive and heterogeneous group of gastrointestinal cancers that arise from the intra- or extrahepatic bile ducts (CCA), or the gallbladder (GBC)(1-3). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholangiocarcinoma Resectable
- What is being tested?
- Gemcitabine/Cisplatin/Nab-Paclitaxel and Rilvegostomig
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 15 Dec 2024to 31 Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient must be capable of providing written informed consent.
- Age >18 years at time of study entry
- Histologically proven intrahepatic cholangiocarcinoma
- Complete surgical resection of the tumor must be achievable*. Resection should include a portal lymphadenectomy as per standard of care.
- No prior cytotoxic, targeted or immune therapy
- Have provided archival tumor tissue sample or preferably freshly obtained biopsy of a tumor lesion not previously irradiated for mandatory pre-treatment evaluation (baseline).
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- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
- Estimated life expectancy >3 months
- Exclusion of distant metastases by CT or MRI of abdomen, pelvis, and thorax, bone scan or MRI (if bone metastases are suspected due to clinical signs). Exclusion of the infiltration of any adjacent organs or structures by CT or MRI, indicating an unresectable situation
- If underlying liver cirrhosis, Childs Pugh score of 5 or 6
- If underlying liver disease, ALBI grade ≤2†
- Patients with HBV infection, which is characterized by positive hepatitis B surface antigen (HBsAg) and/or hepatitis B core antibodies (anti-HBcAb) with detectable HBV DNA (≥10 IU/ml or above the limit of detection per local lab standard), must be treated with antiviral therapy, as per institutional practice, to ensure adequate viral suppression (HBV DNA ≤2000 IU/mL) prior to study entry. Patients must remain on antiviral therapy for the study duration and for 6 months after the last dose of study medication. Patients who test positive for anti-hepatitis B core (HBc) with undetectable HBV DNA (<10 IU/ml or under limit of detection per local lab standard) do not require anti-viral therapy prior to study entry. These subjects will be tested at every cycle to monitor HBV DNA levels and initiate antiviral therapy if HBV DNA is detected (≥10 IU/ml or above the limit of detection per local lab standard). HBV DNA detectable subjects must initiate and remain on antiviral therapy for the study duration and for 6 months after the last dose of study medication.
- Patients with HCV infection must have management of this disease per local institutional practice throughout the study. HCV diagnosis is characterized by the presence of detectable HCV ribonucleic acid (RNA) or anti-HCV antibody upon enrollment.
- Evidence of post-menopausal status or negative serum pregnancy test for female pre-menopausal patients.
- Adequate normal organ and marrow function as defined below within screening period:
- Haemoglobin ≥9.0 g/dL
- Absolute neutrophil count (ANC ≥1.0 × 109 /L)
- Platelet count ≥100 × 109/L
- Serum bilirubin ≤1.5 x institutional upper limit of normal (ULN). <<This will not apply to patients with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician.
- AST (SGOT)/ALT (SGPT) ≤5 x institutional upper limit of normal.
- Measured creatinine clearance (CL) >50 mL/min or Calculated creatinine clearance
- CL>50 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance:
- Males:
- Creatinine CL (mL/min) = Weight (kg) x (140 - Age) 72 x serum creatinine (mg/dL)
- Females:
- Creatinine CL (mL/min) = Weight (kg) x (140 - Age) x 0.85 72 x serum creatinine (mg/dL)
- Albumin ≥2.8g/dl
- International normalized ratio ≤1.5 (for patients receiving Warfarin, please consult with the study physician)
- Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
- Resectability is at the discretion of the investigators at each site but must be discussed at a multidisciplinary tumour board.
- based on albumin and bilirubin; ALBI score = (log10 bilirubin [umol/L] x0.66) + (albumin [g/L] x -0.0852). ALBI grade 1= score ≤ -2.60.
Who cannot join
- Patients should not enter the study if any of the following exclusion criteria are fulfilled at time of study enrolment or where indicated:
- Locally unresectable tumor or metastatic disease:
- Radiological evidence suggesting inability to resect with curative intent whilst maintaining adequate vascular inflow and outflow
- Radiological evidence of direct invasion into adjacent organs.
- Radiological evidence of extrahepatic metastatic disease (except regional lymph nodes - stations 9 and 12
- Contraindication to any of the study drugs
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- Any concurrent chemotherapy, investigational product, biologic or hormonal therapy for cancer treatment
- Are currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks or for a period of at least 5 half-lives of the respective drug/IMP (whichever is longer) before screening and during Screening for this trial.
- Have a diagnosis of immunodeficiency or are receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
- Have a known additional malignancy that is progressing or has required active treatment within the past 2 years.
- Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.
- Have active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed.
- Have a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
- Have an active infection requiring systemic therapy (exception: HBV and HCV infection).
- Have a history of Human Immunodeficiency Virus (HIV) (mandatory testing for HIV during screening is required).
- Have known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ highly effective birth control from screening to 6 months after the last dose of study treatment. Not engaging in sexual activity, per the patient's preferred and usual lifestyle, for the total duration of the treatment and 6 months after the last dose of study treatment is an acceptable practice.
- Note: Females of childbearing potential are defined as those who are not surgically sterile (ie, bilateral salpingectomy, bilateral oophorectomy, or complete hysterectomy) or not post menopausal.
- Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:
- Women <50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution.
- Women ≥50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses >1 year ago, or had chemotherapy-induced menopause with last menses >1 year ago.
- Women who are surgically sterile (i.e., bilateral salpingectomy, bilateral oophorectomy, or complete hysterectomy) are eligible.
- Highly effective methods of contraception, defined as one that results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly. Note that some contraception methods are not considered highly effective (e.g., male or female condom with or without spermicide; female cap, diaphragm, or sponge with or without spermicide; non copper containing intrauterine device; progestogen-only oral hormonal contraceptive pills where inhibition of ovulation is not the primary mode of action [excluding Cerazette/desogestrel, which is considered highly effective]; and triphasic combined oral contraceptive pills). Serum levels of contraceptive hormones may be altered by concomitant use of other drugs. Therefore, drug interactions should always be considered when prescribing hormonal contraception; there could be a risk of contraceptive failure or other adverse effects.
- Legal incapacity or limited legal capacity.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
University Health Network, Toronto General Hospital
Toronto, Ontario, M5G 2C4
Gonzalo Sapisochin, MD, 416-340-4800 ext. 5169, gonzalo.sapisochin@uhn.ca
Roxana Bucur, 437-772-4354, roxana.bucur@uhn.ca
About this study
Official title: Perioperative Therapy With Gemcitabine/Cisplatin/Nab-Paclitaxel and Rilvegostomig for Patients With Resectable Intrahepatic Cholangiocarcinoma (iCCA) - A Phase II Trial
Biliary tract cancer is a highly aggressive and heterogeneous group of gastrointestinal cancers that arise from the intra- or extrahepatic bile ducts (CCA), or the gallbladder (GBC)(1-3). While it accounts for only 0.7% of all malignant tumors and 3% of all gastrointestinal malignancies in adults, both incidence and mortality are increasing. Biliary tract cancers usually present at an advanced stage, with only approximately 20% of patients being diagnosed with an early-stage disease (1, 2, 4). There is a high risk of recurrence post curative radical resection, with 60-70% of patients recurring within 5 years, with 5-year survival of around 25% (1, 2, 5). There is evidence for use of adjuvant chemotherapy with fluoropyrimidine- based regimens as per the BILCAP and ASCOT phase III trials [(5-7).However, despite advances in adjuvant treatment, recurrence rates after resection of BTC remain high even with adjuvant chemotherapy. For example, in the BILCAP study, 5-year RFS was reported as 33.9% (95% CI: 27.6 to 40.2) (1). Therefore, an unmet need exists to optimize peri-operative treatment to reduce recurrence and improve outcomes in patients with resectable BTC.
Read the detailed description
The only curative management for iCCA is radical surgical resection. However, less than 35% of patients present with resectable disease at diagnosis, and postoperative recurrence and relapse rates are around 50-70%. Despite advances in diagnostics and therapeutic interventions, prognosis remains poor with an overall 5-year survival of less than 20%.1
The results of the TOPAZ-12 and KEYNOTE-9663 study have established PD-L1 (durvalumab) and PD-1 (pembrolizumab) inhibition in combination with gemcitabine and cisplatin as a new standard of care highlighting the role of immune checkpoint inhibition in advanced biliary tract cancer (BTC). In addition, the combination of Nab-Paclitaxel and gemcitabine, cisplatin has demonstrated efficacy in advanced BTC4. Several clinical trials evaluating the efficacy of neoadjuvant combinational therapy with gemcitabine, cisplatin and PD-L1 inhibition are ongoing (NCT04989218, NCT06050252, NCT04308174). Neoadjuvant treatment in iCCA allows for delivery of treatment pre surgery and can induce pathological responses and thereby improve survival. Rilvegostomig is a novel anti-TIGIT/anti-PD-1 bispecific antibody that is currently investigated in a Phase I/II clinical trial (ARTEMIDE-01, NCT04995523) for advanced or metastatic PD-L1-positive non-small cell lung cancer. The study provided promising preliminary evidence on the safety and efficacy of Rilvegostomig.5,6 Furthermore, a Phase III clinical trial (ARTEMIDE-Biliary01) using Rilvegostomig in combination with Capecitabine or Gemcitabine/Cisplatin or S-1 as adjuvant therapy for BTC after resection is underway. The efficacy of Gemcitabine/Cisplatin/Nab-Paclitaxel and Rilvegostomig as neoadjuvant treatment in resectable iCCA has yet to be established.
This is a phase II, open-label multi-centre study to assess efficacy of Gemcitabine/Cisplatin/Nab-Paclitaxel and Rilvegostomig treatment in pre-surgical setting for upfront resectable iCCA, followed by adjuvant Gemcitabine/Cisplatin and Rilvegostomig.
40 patients are expected to enrol with resectable iCCA at three sites. Patients will receive prior to surgery: 2 cycles of combinational therapy with Gemcitabine (800mg) /Cisplatin (25mg) /Nab-Paclitaxel (100mg) and Rilvegostomig (Q3W). Post-surgical resection, adjuvant therapy will consist of 4 cycles of Gemcitabine (1000mg) /Cisplatin (25mg) and Rilvegostomig (Q3W). Rilvegostomig (Q3W) will be continued for a total of 12 months in the adjuvant phase.
All participants will be followed for survival until the end of study.
Dosing of Gemcitabine/Cisplatin/Nab-Paclitaxel and Rilvegostomig may be delayed per the trial management group's discretion but dose reduction will not be allowed. Toxicity management for Gemcitabine/Cisplatin/Nab-Paclitaxel and Rilvegostomig-related toxicity, including management of immune-mediated reactions, infusion-related reactions, and non-immune-mediated reactions will be provided in the Toxicity Management Guidelines
- Conditions
- Cholangiocarcinoma Resectable
- Being tested
- Gemcitabine/Cisplatin/Nab-Paclitaxel and Rilvegostomig
- Keywords
- CCA, Biliary cancer, Neo-adjuvant and adjuvant therapy
- Medical subject headings
- Biliary Tract Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gemcitabine/Cisplatin/Nab-Paclitaxel and RilvegostomigDrug
: Patients will receive prior to surgery: 2 cycles of combinational therapy with Gemcitabine (800mg) /Cisplatin (25mg) /Nab-Paclitaxel (100mg) and Rilvegostomig (Q3W). Post-surgical resection, adjuvant therapy will consist of 4 cycles of Gemcitabine (1000mg) /Cisplatin (25mg) and Rilvegostomig (Q3W). Rilvegostomig (Q3W) will be continued for a total of 12 months in the adjuvant phase
| Study group | Role | What they receive |
|---|---|---|
| Gemcitabine/Cisplatin/Nab-Paclitaxel and Rilvegostomig | Experimental | Not described Receives: Drug: Gemcitabine/Cisplatin/Nab-Paclitaxel and Rilvegostomig |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major pathological response (MPR), defined as >70% tumor necrosis
To determine pathological response rate to neoadjuvant Gemcitabine/Cisplatin/Nab-Paclitaxel and Rilvegostomig in resected tumour
Measured: 2 years
Secondary outcomes (4)
Objective response rate (ORR)
To determine the radiologic objective response rate (ORR) to neoadjuvant Gemcitabine/Cisplatin/Nab-Paclitaxel and Rilvegostomig.
Measured: 3 years
The number of patients who experience a surgical delay and/or drop off due to treatment related adverse events (TRAEs) or progressive disease
To assess feasibility of pre-operative treatment of Gemcitabine/Cisplatin/Nab-Paclitaxel and Rilvegostomig
Measured: 2 years
The number of ≥ grade 3 adverse events (AEs) or immune related adverse events that occur during treatment
To assess safety of pre-operative treatment with Gemcitabine/Cisplatin/Nab-Paclitaxel and Rilvegostomig.
Measured: 3 years
Rate of R0
Number of resections with negative margins
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start15 Dec 2024 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cholangiocarcinoma ResectableStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Sunnybrook Health Sciences Centre, Hamilton Health Sciences Corporation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06569225
- Sponsor's protocol ID
- 24-5716
- Acronym
- NEOLANGIO
- Status last verified
- Aug 2024
- First submitted
- 21 Aug 2024
- Last updated
- 26 Aug 2024
- 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 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Therapy With Gemcitabine/Cisplatin/Nab-Paclitaxel and Rilvegostomig for Patients With Resectable Intrahepatic Cholangiocarcinoma (iCCA) - A Phase II Trial
- ClinicalTrials.gov ID
- NCT06569225
- Acronym / sponsor ID
- NEOLANGIO / 24-5716
- Conditions
- Cholangiocarcinoma Resectable
- Keywords
- CCA, Biliary cancer, Neo-adjuvant and adjuvant therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Sunnybrook Health Sciences Centre, Hamilton Health Sciences Corporation
- Study start
- 15 Dec 2024 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 26 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.
Biliary tract cancer is a highly aggressive and heterogeneous group of gastrointestinal cancers that arise from the intra- or extrahepatic bile ducts (CCA), or the gallbladder (GBC)(1-3). While it accounts for only 0.7% of all malignant tumors and 3% of all gastrointestinal malignancies in adults, both incidence and mortality are increasing. Biliary tract cancers usually present at an advanced stage, with only approximately 20% of patients being diagnosed with an early-stage disease (1, 2, 4). There is a high risk of recurrence post curative radical resection, with 60-70% of patients recurring within 5 years, with 5-year survival of around 25% (1, 2, 5). There is evidence for use of adjuvant chemotherapy with fluoropyrimidine- based regimens as per the BILCAP and ASCOT phase III trials [(5-7).However, despite advances in adjuvant treatment, recurrence rates after resection of BTC remain high even with adjuvant chemotherapy. For example, in the BILCAP study, 5-year RFS was reported as 33.9% (95% CI: 27.6 to 40.2) (1). Therefore, an unmet need exists to optimize peri-operative treatment to reduce recurrence and improve outcomes in patients with resectable BTC.
Detailed description
The only curative management for iCCA is radical surgical resection. However, less than 35% of patients present with resectable disease at diagnosis, and postoperative recurrence and relapse rates are around 50-70%. Despite advances in diagnostics and therapeutic interventions, prognosis remains poor with an overall 5-year survival of less than 20%.1
The results of the TOPAZ-12 and KEYNOTE-9663 study have established PD-L1 (durvalumab) and PD-1 (pembrolizumab) inhibition in combination with gemcitabine and cisplatin as a new standard of care highlighting the role of immune checkpoint inhibition in advanced biliary tract cancer (BTC). In addition, the combination of Nab-Paclitaxel and gemcitabine, cisplatin has demonstrated efficacy in advanced BTC4. Several clinical trials evaluating the efficacy of neoadjuvant combinational therapy with gemcitabine, cisplatin and PD-L1 inhibition are ongoing (NCT04989218, NCT06050252, NCT04308174). Neoadjuvant treatment in iCCA allows for delivery of treatment pre surgery and can induce pathological responses and thereby improve survival. Rilvegostomig is a novel anti-TIGIT/anti-PD-1 bispecific antibody that is currently investigated in a Phase I/II clinical trial (ARTEMIDE-01, NCT04995523) for advanced or metastatic PD-L1-positive non-small cell lung cancer. The study provided promising preliminary evidence on the safety and efficacy of Rilvegostomig.5,6 Furthermore, a Phase III clinical trial (ARTEMIDE-Biliary01) using Rilvegostomig in combination with Capecitabine or Gemcitabine/Cisplatin or S-1 as adjuvant therapy for BTC after resection is underway. The efficacy of Gemcitabine/Cisplatin/Nab-Paclitaxel and Rilvegostomig as neoadjuvant treatment in resectable iCCA has yet to be established.
This is a phase II, open-label multi-centre study to assess efficacy of Gemcitabine/Cisplatin/Nab-Paclitaxel and Rilvegostomig treatment in pre-surgical setting for upfront resectable iCCA, followed by adjuvant Gemcitabine/Cisplatin and Rilvegostomig.
40 patients are expected to enrol with resectable iCCA at three sites. Patients will receive prior to surgery: 2 cycles of combinational therapy with Gemcitabine (800mg) /Cisplatin (25mg) /Nab-Paclitaxel (100mg) and Rilvegostomig (Q3W). Post-surgical resection, adjuvant therapy will consist of 4 cycles of Gemcitabine (1000mg) /Cisplatin (25mg) and Rilvegostomig (Q3W). Rilvegostomig (Q3W) will be continued for a total of 12 months in the adjuvant phase.
All participants will be followed for survival until the end of study.
Dosing of Gemcitabine/Cisplatin/Nab-Paclitaxel and Rilvegostomig may be delayed per the trial management group's discretion but dose reduction will not be allowed. Toxicity management for Gemcitabine/Cisplatin/Nab-Paclitaxel and Rilvegostomig-related toxicity, including management of immune-mediated reactions, infusion-related reactions, and non-immune-mediated reactions will be provided in the Toxicity Management Guidelines
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gemcitabine/Cisplatin/Nab-Paclitaxel and Rilvegostomig | Experimental | Drug: Gemcitabine/Cisplatin/Nab-Paclitaxel and Rilvegostomig |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (31 listed)
- Patient must be capable of providing written informed consent.
- Age >18 years at time of study entry
- Histologically proven intrahepatic cholangiocarcinoma
- Complete surgical resection of the tumor must be achievable*. Resection should include a portal lymphadenectomy as per standard of care.
- No prior cytotoxic, targeted or immune therapy
Key exclusion criteria (24 listed)
- Patients should not enter the study if any of the following exclusion criteria are fulfilled at time of study enrolment or where indicated:
- Locally unresectable tumor or metastatic disease:
- Contraindication to any of the study drugs
- Any concurrent chemotherapy, investigational product, biologic or hormonal therapy for cancer treatment
- Are currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks or for a period of at least 5 half-lives of the respective drug/IMP (whichever is longer) before screening and during Screening for this trial.
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 |
|---|---|---|
| Gemcitabine/Cisplatin/Nab-Paclitaxel and Rilvegostomig: Patients will receive prior to surgery: 2 cycles of combinational therapy with Gemcitabine (800mg) /Cisplatin (25mg) /Nab-Paclitaxel (100mg) and Rilvegostomig (Q3W). Post-surgical resection, adjuvant therapy will consist of 4 cycles of Gemcitabine (1000mg) /Cisplatin (25mg) and Rilvegostomig (Q3W). Rilvegostomig (Q3W) will be continued for a total of 12 months in the adjuvant phase | Drug | Gemcitabine/Cisplatin/Nab-Paclitaxel and Rilvegostomig |
Primary outcome
Major pathological response (MPR), defined as >70% tumor necrosis
Time frame: 2 years
To determine pathological response rate to neoadjuvant Gemcitabine/Cisplatin/Nab-Paclitaxel and Rilvegostomig in resected tumour
4 secondary outcomes
Objective response rate (ORR)
Time frame: 3 years
The number of patients who experience a surgical delay and/or drop off due to treatment related adverse events (TRAEs) or progressive disease
Time frame: 2 years
The number of ≥ grade 3 adverse events (AEs) or immune related adverse events that occur during treatment
Time frame: 3 years
Rate of R0
Time frame: 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 26 Aug 2024.
- 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.
University Health Network, Toronto General Hospital
Toronto, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gemcitabine/Cisplatin/Nab-Paclitaxel and Rilvegostomig in people with Cholangiocarcinoma Resectable, run by University Health Network, Toronto at 1 site in Canada.
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 31 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 26 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 Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major pathological response (MPR), defined as >70% tumor necrosis (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2024.