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Intrahepatic CholangiocarcinomaPhase 2NCT04961788

Anti-PD1 Antibody Toripalimab Combined With Gemox as First-line Therapy in Late-stage Intrahepatic Cholangiocarcinoma

A Phase 2 study testing Gemox combimed PD1 antibody in people with Intrahepatic Cholangiocarcinoma, run by Shanghai Zhongshan Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

To explore the objective response rate and safety of toripalimab combined with Gemox in the first-line treatment of progressive, metastatic or unresectable advanced ICC. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Intrahepatic Cholangiocarcinoma
What is being tested?
Gemox combimed PD1 antibody
Type of treatment
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 Jul 2021to 31 Dec 2022
Phase
Phase 2
Are there results?
None posted in the registry

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

  • 1. The patient must sign an informed consent form; 2. Age 18-75 years old, both male and female; 3. ECOG performance status score (PS score) 0 or 1 point; 4. Child-Pugh score A period; 5. Intrahepatic cholangiocarcinoma confirmed by histopathology; agree to provide previously stored tumor tissue specimens or fresh biopsy tumor lesions; 6. Unresectable ICC patients or postoperative diagnosis of ICC recurrence and metastasis, and have not received systemic treatment within 6 months; 7. The functional indicators of important organs meet the following requirements
  • Neutrophils≥1.5*109/L; platelets≥100*109/L; hemoglobin≥9g/dl; serum albumin≥3g/dl;
  • Thyroid-stimulating hormone (TSH) ≤ 2 times the upper limit of normal, and T3 and T4 are in the normal range;
  • Bilirubin ≤ 1.5 times the upper limit of normal; ALT and AST ≤ 3 times the upper limit of normal;
  • Serum creatinine ≤ 1.5 times the upper limit of normal, and creatinine clearance ≥ 60ml/min (calculated by Cockcroft-Gault formula); 8. The subject has at least 1 measurable lesion (according to RECIST1.1); 9. For women who are not breastfeeding or pregnant, use contraception during treatment or 3 months after the end of treatment.

Who cannot join

  • 1. Pathological diagnosis of hepatocellular carcinoma, mixed hepatocellular carcinoma, and other malignant components of non-cholangiocarcinoma; 2. Past or simultaneous suffering from other malignant tumors, except for fully treated non-melanoma skin cancer, cervical carcinoma in situ, and thyroid papillary carcinoma; 3. Have used gemcitabine-based chemotherapy or have used PD-1 monoclonal antibody or PD-L1 monoclonal antibody treatment within 6 months; 4. Severe cardiopulmonary and renal dysfunction; 5. Hypertension that is difficult to control with drugs (systolic blood pressure (BP) ≥140 mmHg and/or diastolic blood pressure ≥90mmHg) (based on the average of ≥3 BP readings obtained by ≥2 measurements); 6. Abnormal coagulation function (PT>14s), have bleeding tendency or are receiving thrombolysis or anticoagulation therapy; 7. After antiviral treatment, HBV DNA>2000 copies/ml, HCV RNA>1000; 8. A history of esophageal and gastric varices, significant clinically significant bleeding symptoms or a clear tendency to appear within 3 months before enrollment; 9. Active infections requiring systemic treatment; patients with active tuberculosis infection within 1 year before enrollment; a history of active tuberculosis infection more than 1 year before enrollment, and no formal anti-tuberculosis treatment or tuberculosis Still in the active period; 10. Human immunodeficiency virus (HIV, HIV1/2 antibody) positive; 11. A history of psychotropic drug abuse, alcohol or drug abuse; 12. Known to have a history of severe allergies to any monoclonal antibodies, platinum drugs, or gemcitabine; 13. Other factors judged by the investigator may affect the safety of the subjects or the compliance of the trial. Such as serious diseases (including mental illness) that require combined treatment, serious laboratory abnormalities, or other family or social factors.

Trial locations and contacts

1 site in 1 country.

xiaoyong Huang, MD contact

+8615021519215

huang.xiaoyong@zs-hospital.sh.cn

Guo-ming Shi, MD contact

+8613916969578

shi.guoming@zs-hospital.sh.cn

China1 site, 1 recruiting

  • Zhongshan hospital

    Shanghai, Shanghai Municipality, 200032

    xiaoyong Huang, MD, +8615021519215, huang.xiaoyong@zs-hospital.sh.cn

    Guo-Ming Shi, MD, +8613916969578, shi.guoming@zs-hospital.sh.cn

    Recruiting

Other trials in China

About this study

Official title: A Phase 2 Study of Anti-PD1 Antibody Toripalimab Combined With Gemox (Gemcitabine and Oxaliplatin) as First-line Therapy in Patients With Advanced or Unresectable Intrahepatic Cholangiocarcinoma

To explore the objective response rate and safety of toripalimab combined with Gemox in the first-line treatment of progressive, metastatic or unresectable advanced ICC.

Read the detailed description

Studies have shown that the Gemox chemotherapy (oxaliplatin + gemcitabine) in patients with advanced biliary tract cancer has an objective response rate (ORR) of 22% (95% CI 6.5-37.4%) and a stable disease rate of 30%. The progression rate was 48%, the tumor progression-free survival (PFS) was 3.9 months and the overall survival (OS) was 7.6 months. In recent years, monoclonal antibodies against programmed cell death protein 1 (PD1) and programmed cell death ligand 1 (PD-L1) such as nivolumab, Pembrolizumab, and Toripalimab. It has shown encouraging effects in the treatment of a variety of solid tumors. For advanced cholangiocarcinoma that cannot be resected or is accompanied by metastasis, NCCN guidelines (NCCN guidelines hepatobiliary cancer, 2020) recommend that the current treatment options are limited, and gemcitabine combined with platinum anti-tumor drugs (cisplatin, oxaliplatin, etc.) are recommended. Chemotherapy regimen as first-line treatment. For those with microsatellite instability, it is recommended to add a PD1 monoclonal antibody. The guidelines also specifically stated that the above recommendations lack evidence support from phase III clinical trials and encourage the development of clinical trial research. PD1 monoclonal antibody combined with chemotherapy in the treatment of advanced ICC may have a better effect than chemotherapy alone. Currently, as a first-line treatment, there is no research report on PD1 monoclonal antibody combined with Gemox in the treatment of advanced ICC.

Being tested
Gemox combimed PD1 antibody
Keywords
intrahepatic Cholangiocarcinoma, Gemox chemotherapy, PD1 antibody
Medical subject headings
Cholangiocarcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Gemox combimed PD1 antibodyDrug

    1. Toripalimab (240mg) intravenously, the administration time is 60 (+15) minutes, Q3W is administered once.
    2. Gemox chemotherapy D1: oxaliplatin 85mg/m2, gemcitabine 1g/m2 D8: Gemcitabine 1g/m2 Three weeks is a course of treatment, a total of 6-8 courses.
Study groups in NCT04961788
Study groupRoleWhat they receive
Gemox combined PD1 antibodyExperimental1. Toripalimab (240mg) intravenously, the administration time is 60 (+15) minutes, Q3W is administered once. 2. Gemox chemotherapy D1: oxaliplatin 85mg/m2, gemcitabine 1g/m2 D8: Gemcitabine 1g/m2 Three weeks is a course of treatment, a total of 6-8 courses.
Receives: Drug: Gemox combimed PD1 antibody

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective response rate

    Objective response rate of advanced and unresectable in intrahepatic cholangiocarcinoma

    Measured: 12 months

Secondary outcomes (3)

  1. Safety:The potential side effects

    The potential side effects

    Measured: 12 months

  2. Overall survival

    From the beginning date to the date of death

    Measured: 18 months

  3. Progression free survival

    From the beginning date to the date of disease progression

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jul 2021
  2. Study start1 Jul 2021
  3. Primary completion31 Dec 2021 (estimated)
  4. Study completion31 Dec 2022 (estimated)

Resources

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
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04961788
Sponsor's protocol ID
ICC-zs-2021
Status last verified
Jul 2021
First submitted
7 Jul 2021
Last updated
14 Jul 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Andre T, Tournigand C, Rosmorduc O, Provent S, Maindrault-Goebel F, Avenin D, Selle F, Paye F, Hannoun L, Houry S, Gayet B, Lotz JP, de Gramont A, Louvet C; GERCOR Group. Gemcitabine combined with oxaliplatin (GEMOX) in advanced biliary tract adenocarcinoma: a GERCOR study. Ann Oncol. 2004 Sep;15(9):1339-43. doi: 10.1093/annonc/mdh351.

    PubMed 15319238

  • Wang FH, Wei XL, Feng J, Li Q, Xu N, Hu XC, Liao W, Jiang Y, Lin XY, Zhang QY, Yuan XL, Huang HX, Chen Y, Dai GH, Shi JH, Shen L, Yang SJ, Shu YQ, Liu YP, Wang W, Wu H, Feng H, Yao S, Xu RH. Efficacy, Safety, and Correlative Biomarkers of Toripalimab in Previously Treated Recurrent or Metastatic Nasopharyngeal Carcinoma: A Phase II Clinical Trial (POLARIS-02). J Clin Oncol. 2021 Mar 1;39(7):704-712. doi: 10.1200/JCO.20.02712. Epub 2021 Jan 25.

    PubMed 33492986

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Gemox combimed PD1 antibody in people with Intrahepatic Cholangiocarcinoma, run by Shanghai Zhongshan Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 14 Jul 2021. 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 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact xiaoyong Huang, MD (+8615021519215, huang.xiaoyong@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04961788, which also lists 2 linked publications.

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 14 Jul 2021.

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