Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a randomized, double-blind, placebo-controlled Ib/â…¡ clinical study to evaluate the safety and effect of anti-PD-L1 antibody (ZKAB001) in neoadjuvant chemotherapy of esophageal squamous carcinoma in combination with Alb-paclitaxel and cisplatin. The immunotherapy will be given before and after the operation every three weeks.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PD-L1 group | Experimental | All patients will receive 16 cycles of anti-PD-L1 antibody (5mg/kg, IV, every 3 weeks) , concurrently with 4 cycles of albumin-bound paclitaxel and cisplatin (albumin-bound paclitaxel 125mg/m2 on days 1, 8 and cisplatin 75 mg/m2 on day 1 every 3 weeks). |
|
| placebo group | Placebo Comparator | All patients will receive 4 cycles of placebo ( IV, every 3 weeks) , concurrently with 4 cycles of albumin-bound paclitaxel and cisplatin (albumin-bound paclitaxel 125mg/m2 on days 1, 8 and cisplatin 75 mg/m2 on day 1 every 3 weeks). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| anti-PD-L1 antibody | Drug | Patients will receive 16 cycles of anti-PD-L1 antibody 5mg/kg IV on day 1 every 3 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| major pathologic response rate | The rate of pathologic 1a and 1b after neoadjuvant chemotherapy. | Two weeks after surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| R0 resection rate | The R0 resection rate of esophagectomy. | Two weeks after surgery. |
| pathological complete response rate | The rate of pathologic 1a after neoadjuvant chemotherapy. |
Not provided
Key inclusion Criteria:
Aged 18 to 75 years old of either gender;
A histopathological diagnosis of esophageal squamous cell carcinoma with a clinical stage of T2N+M0 or T3-4aN+/-M0 according to the 8th edition of the UICC staging system;
ECOG score 0-1;
Estimated life expectancy >3 months;
BMI ≥18.5kg/m2 or PG-SGA score A/B;
The function of important organs meets the following requirements:
Cardiac function: ≤I, pulmonary function: FEV1 >1.2L, FEV1% >40%, liver function: Child-Pugh 5-6;
Serum HCG negative in premenopausal women ;
Ability to understand the study and sign informed consent.
Key exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| SHUGENG GAO, MD | Chinese Academy of Medical Sciences and Peking Union Medical College | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese Academy of Medical Sciences and Peking Union Medical College | Beijing | Beijing Municipality | 100000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9869669 | Background | Kelsen DP, Ginsberg R, Pajak TF, Sheahan DG, Gunderson L, Mortimer J, Estes N, Haller DG, Ajani J, Kocha W, Minsky BD, Roth JA. Chemotherapy followed by surgery compared with surgery alone for localized esophageal cancer. N Engl J Med. 1998 Dec 31;339(27):1979-84. doi: 10.1056/NEJM199812313392704. | |
| 17028244 | Background |
| Label | URL |
|---|---|
| GLOBOCAN 2018: oesophagus cancer fact sheet | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068196 | Albumin-Bound Paclitaxel |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| albumin bound paclitaxel | Drug | Patients will receive 4 cycles of albumin bound paclitaxel 125mg/m2 on days 1, 8 every 3 weeks . |
|
|
| cisplatin | Drug | Patients will receive 4 cycles of cisplatin 75mg/m2 on day 1 every 3 weeks. |
|
| placebo | Drug | Patients will receive 4 cycles of placebo IV on day 1 every 3 weeks. |
|
| radical resection of esophageal carcinoma | Procedure | Patients will receive radical resection of esophageal carcinoma after 4 cycles of chemotherapy. |
|
| Two weeks after surgery. |
| disease free survival | The 2-year disease free survival of the whole group. | From the date of surgery until the date of death due to disease progression or the date of first documented disease progression whichever came first, assessed up to 24 months. |
| disease free survival rate | The 2-year disease free survival rate of the whole group. | From the date of surgery until the date of death due to disease progression or the date of first documented disease progression whichever came first, assessed up to 24 months. |
| event free survival | The 2-year event free survival of the whole group. | From the date of randomization until the date of death from any cause or the date of first documented disease progression whichever came first, assessed up to 24 months. |
| event free survival rate | The 2-year event free survival rate of the whole group. | From the date of randomization until the date of death from any cause or the date of first documented disease progression whichever came first, assessed up to 24 months. |
| overall survival rate | The 2-year overall survival rate of the whole group. | From the date of randomization until the date of death from any cause or the date of last follow-up whichever came first, assessed up to 24 months. |
| overall survival | The 2-year overall survival of the whole group. | From the date of randomization until the date of death from any cause or the date of last follow-up whichever came first, assessed up to 24 months. |
| adverse events rate | The incidence rate of treatment-related adverse events of the whole group assessed by CTCAE v5.0. | From the date of randomization to 90 days after the last chemotherapy. |
| Lin CC, Hsu CH, Cheng JC, Wang HP, Lee JM, Yeh KH, Yang CH, Lin JT, Cheng AL, Lee YC. Concurrent chemoradiotherapy with twice weekly paclitaxel and cisplatin followed by esophagectomy for locally advanced esophageal cancer. Ann Oncol. 2007 Jan;18(1):93-98. doi: 10.1093/annonc/mdl339. Epub 2006 Oct 6. |
| 12881388 | Background | Polee MB, Tilanus HW, Eskens FA, Hoekstra R, Van der Burg ME, Siersema PD, Stoter G, Van der Gaast A. Phase II study of neo-adjuvant chemotherapy with paclitaxel and cisplatin given every 2 weeks for patients with a resectable squamous cell carcinoma of the esophagus. Ann Oncol. 2003 Aug;14(8):1253-7. doi: 10.1093/annonc/mdg328. |
| 25379852 | Background | Shapiro J, van Hagen P, Lingsma HF, Wijnhoven BP, Biermann K, ten Kate FJ, Steyerberg EW, van der Gaast A, van Lanschot JJ; CROSS Study Group. Prolonged time to surgery after neoadjuvant chemoradiotherapy increases histopathological response without affecting survival in patients with esophageal or junctional cancer. Ann Surg. 2014 Nov;260(5):807-13; discussion 813-4. doi: 10.1097/SLA.0000000000000966. |
| 36882775 | Derived | Li Y, Zhou A, Liu S, He M, Chen K, Tian Z, Li Y, Qin J, Wang Z, Chen H, Tian H, Yu Y, Qu W, Xue L, He S, Wang S, Bie F, Bai G, Zhou B, Yang Z, Huang H, Fang Y, Li B, Dai X, Gao S, He J. Comparing a PD-L1 inhibitor plus chemotherapy to chemotherapy alone in neoadjuvant therapy for locally advanced ESCC: a randomized Phase II clinical trial : A randomized clinical trial of neoadjuvant therapy for ESCC. BMC Med. 2023 Mar 8;21(1):86. doi: 10.1186/s12916-023-02804-y. |
| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |