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Biliary Tract Neoplasms

Gastrointestinal Neoplasms

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Biliary Tract Diseases

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Biliary Tract Cancer

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Amino Acids

Gemcitabine

Lenvatinib

Apatinib

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Adebrelimab, 20 mg/kg, 30-minute intravenous infusion, once every 3 weeks (Q3W)

TKI:

Lenvatinib: 12 mg (3 capsules 4 mg) or 8 mg (2 capsules 4 mg) QD Apatinib: 250 mg orally, QD, 5 days on 2 days off or QOD Sorafenib: 0.4g (2 × 0.2g) twice or once daily Anlotinib: 12 mg orally before breakfast, QD. The drug was taken continuously for 2 weeks and stopped for 1 week.

GEMOX:

Gemcitabine 800mg/m2 and oxaliplatin 85mg/m2, IV, D2, D15, D29, until 6 cycles of treatment

Adebrelimab 20 mg/kg, once every 3 weeks (Q3W), maintained for 1 year. The interval between two doses should not be less than 12 days.

Tyrosine kinase inhibitor (TKI) Lenvatinib: 12 mg (3 capsules 4 mg) or 8 mg (2 capsules 4 mg) once daily (QD) at fixed times daily, on an empty stomach or with food; Apatinib: 250mg orally, QD, 5 days of medication, 2 days off (5 on 2 off) or once every other day (QOD), half an hour after meals; Sorafenib: 0.4g (2 × 0.2g) twice or once daily on an empty stomach or with a low-fat or medium-fat diet Anlotinib: 12 mg orally before breakfast, QD. The drug was taken continuously for 2 weeks and stopped for 1 week.

GEMOX: gemcitabine 800mg/m2 and oxaliplatin 85mg/m2, intravenous infusion, D2, D15, D29, until 6 cycles of treatment were completed, or the patients who did not reach 6 cycles had intolerable adverse reactions, then the combination chemotherapy was terminated.

Adebrelimab + GEMOX + TKI

Wenbin Li, archiater

Junkai Ren

Wenbin Li

Patients with advanced biliary tract malignant tumors who had not received systematic treatment before and could not be cured were selected as the subjects of the study. The primary endpoint of the study was investigator-assessed 6-month progression-free survival (6-month PFS%) based on the RECIST v1.1 criteria, and 43 subjects were planned to be enrolled. Patients eligible for enrollment will receive Adebrelimab and a tyrosine kinase inhibitor (TKI) in combination with gemcitabine and oxaliplatin (GEMOX).

This is an open-label, single-arm clinical study to observe and evaluate the efficacy and safety of Adebrelimab (PD-L1) and tyrosine kinase inhibitor (TKI) combined with gemcitabine and oxaliplatin (GEMOX) in the first-line treatment of patients with advanced biliary tract malignancies.

Subjects will be screened to receive Adebrelimab and TKI in combination with Gemcitabine and Oxaliplatin (GEMOX) after they are fully informed and sign the informed consent. Study treatment will continue until the subject develops intolerable toxicity, withdraws informed consent, and progresses as determined by the investigator in accordance with RECIST v1.1 (when the subject develops disease progression as defined in RECIST v1.1, if the investigator assesses that the subject continues to have clinical benefit and can tolerate the study treatment, The subject may continue treatment with the study drug; treatment may be terminated if the subject is no longer considered to have a clinical benefit), or other termination criteria specified in the protocol, whichever occurs first.

After the subjects were enrolled in the study, the safety visit will be conducted in D1 of each treatment cycle, and the safety visit and survival follow-up will be continued after the treatment.

Tumor imaging evaluation Imaging examination was performed every 6 weeks after enrollment to evaluate the efficacy. Additional imaging studies and evaluations may be performed at any time during the study if clinically indicated. Imaging evaluation of the tumor will continue until disease progression is confirmed by the investigator according to the RECIST v1.1 criteria or treatment is discontinued, whichever occurs later. Subjects who ended treatment for reasons other than investigator-confirmed disease progression (per RECIST v1.1) will also continue to be followed up at regular intervals for tumor imaging evaluation after the end of treatment.

If the subject withdraws the knowledge, has started other anti-tumor treatment (except Chinese patent medicine) or dies before the disease progression or termination of treatment confirmed by the investigator according to RECIST1.1 criteria, there is no need to continue the imaging evaluation. If the subject fails to meet the above termination criteria for imaging evaluation, the tumor efficacy evaluation of other efficacy evaluation criteria (RECIST v1.1, imRECIST) still needs to be continued even if the disease progression of a certain efficacy evaluation criteria occurs.

Adebrelimab and a TKI in Combination With GEMOX in First-line Treatment of Advanced Biliary Tract Cancers (BTC)

Evaluation of the Efficacy and Safety of Adebrelimab and a TKI in Combination With GEMOX in First-line Treatment of Advanced Biliary Tract Cancers (BTC): a Single-arm, Phase II Clinical Study

Relationship between PD-L1 expression level in tumor tissue, PD-L1strong positive expression rate and the efficacy of Adebrelimab and TKI combined with gemcitabine-oxaliplatin (GEMOX)

To evaluate the efficacy of Adebrelimab and TKI in combination with gemcitabine and oxaliplatin (GEMOX) as first-line treatment for patients with advanced biliary malignancies by assessing PFS based on an immunomodified RECIST (imRECIST）

To evaluate the efficacy of Adebrelimab and TKI in combination with gemcitabine and oxaliplatin (GEMOX) as first-line treatment for patients with advanced biliary malignancies by assessing TTP based on an immunomodified RECIST (imRECIST）

To evaluate the efficacy of Adebrelimab and TKI in combination with gemcitabine and oxaliplatin (GEMOX) as first-line treatment for patients with advanced biliary malignancies by assessing ORR based on an immunomodified RECIST (imRECIST）

To evaluate the efficacy of Adebrelimab and TKI in combination with gemcitabine and oxaliplatin (GEMOX) as first-line treatment for patients with advanced biliary malignancies by assessing DCR based on an immunomodified RECIST (imRECIST）

To evaluate the efficacy of Adebrelimab and TKI in combination with gemcitabine and oxaliplatin (GEMOX) as first-line treatment for patients with advanced biliary malignancies by assessing DoR based on an immunomodified RECIST (imRECIST）

To evaluate the effectiveness of first-line treatment with Adebrelimab and a tyrosine kinase inhibitor (TKI) in combination with gemcitabine and oxaliplatin (GEMOX) in patients with advanced biliary tract cancer by assessing 6-month progression-free survival (6-month PFS%)

To evaluate the effectiveness of Adebrelimab and TKI in combination with gemcitabine and oxaliplatin (GEMOX) as first-line treatment for patients with advanced biliary malignancies by assessing progression-free survival (PFS).

To evaluate the efficacy and safety of Adebrelimab and TKI in combination with gemcitabine and oxaliplatin (GEMOX) in first-line treatment of patients with advanced biliary malignancies by assessing time to progression (TTP)

To evaluate the effectiveness of Adebrelimab and TKI in combination with gemcitabine and oxaliplatin (GEMOX) as first-line treatment for patients with advanced biliary malignancies by assessing disease control rate (DCR),

To evaluate the effectiveness of Adebrelimab and TKI in combination with gemcitabine and oxaliplatin (GEMOX) as first-line treatment for patients with advanced biliary malignancies by assessing objective response rate (ORR)

To evaluate the effectiveness of Adebrelimab and TKI in combination with gemcitabine and oxaliplatin (GEMOX) as first-line treatment for patients with advanced biliary malignancies by assessing duration of response (DoR)

To evaluate the effectiveness of Adebrelimab and TKI in combination with gemcitabine and oxaliplatin (GEMOX) as first-line treatment for patients with advanced biliary malignancies by assessing overall survival (OS).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Adebrelimab and a TKI in Combination With GEMOX in First-line Treatment of Advanced Biliary Tract Cancers (BTC)	NCT06320301	Biliary Tract C... Gemox Chemother...	Adebrelimab + G...	-	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Adebrelimab and a TKI in Combination With GEMOX in First-line Treatment of Advanced Biliary Tract Cancers (BTC)	NCT06320301	Biliary Tract C... Gemox Chemother...	Adebrelimab + G...	-	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Adebrelimab and a TKI in Combination With GEMOX in First-line Treatment of Advanced Biliary Tract Cancers (BTC)	NCT06320301	Biliary Tract C... Gemox Chemother...	Adebrelimab + G...	-	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

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