Neoplasms

Digestive System Diseases

All Conditions

Rare Diseases

Stomach Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Bone Density Conservation Agents

Hematinics

Vitamins

Paclitaxel

Leucovorin

Fluorouracil

Levoleucovorin

Albumin-Bound Paclitaxel

Oxaliplatin

Calcium

Calcium, Dietary

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Antidotes

Protective Agents

Folic Acid

Vitamin B Complex

Trace Elements

Folinic Acid

Folate

Vitamin B9

The POF regimen consisted of a 3-hour infusion of paclitaxel (135 mg/m2) followed by oxaliplatin (85 mg/m2) and Calcium Levofolinate (200 mg/m2).Subsequently, a 46-hour infusion of fluorouracil (2400 mg/m2) was administered using an ambulatory pump, repeating the cycle every 14 days. The combined chemotheraphy will be treated for 9 circle. then，the capetabine was allowed

The regimen consisted of oxaliplatin (85 mg/m2) and Calcium Levofolinate (200 mg/m2) plus paclitaxel (80 mg/m2) intra-peritoneally.Subsequently, a 46-hour infusion of fluorouracil (2400 mg/m2) was administered using an ambulatory pump, repeating the cycle every 14 days.

The FOLFOX regimen consisted of oxaliplatin (85 mg/m2) and Calcium Levofolinate (200 mg/m2).Subsequently, a 46-hour infusion of fluorouracil (2400 mg/m2) was administered using an ambulatory pump, repeating the cycle every 14 days.

Paclitaxel plus Oxaliplatin plus Leucovorin plus 5-FU

FOLFOX

FOLFOX plus PAC(ip)

Rongbo Lin, MD

The aim of this study was to compare the efficacy and safety of POF, FOLFOX, and FOLFOX plus paclitaxel(ip) as first-line treatment in AGC a phase II clinical trial.

The biweekly 5-fluorouracil and leucovorin (LV5FU2) regimen associated with oxaliplatin (FOLFOX) is active in patients with AGC. Meanwhile, Paclitaxel monotherapy is also active in patients with AGC. In previous studies, we found that POF(A combination of oxaliplatin, fluorouracil and Paclitaxel) regimen appears to be of good efficacy and is well tolerated in patients with advanced gastric cancer. This study is being done to find out if three drugs combination maintain manageable side effects but have better benefit than two drugs combination. Intraperitoneal paclitaxel showed high local concentration in abdominal cavity and low systemic toxicity. This study is being done to find out if the combination with Intraperitoneal paclitaxel and FOLFOX have higher local control rate and lower systemic toxicity.

POF Versus FOLFOX Versus FOLFOX Plus ip Paclitaxel in AGC

A Phase 2 Study of POF(Paclitaxel/Oxaliplatin/5-Fluorouracil/Leucovorin) Versus FOLFOX Versus FOLFOX Plus Intraperitoneal Paclitaxel as a First-line Treatment in Advanced Gastric Cancer

The length of time from enrollment until the time of progression of disease (PFS, progression-free survival).

Response rate per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

Clinical response of treatment according to RESIST v1.1 criteria (ORR, According to NCI CTCAE 4.03 criteria

a quality-of-life instrument for use in international clinical trials in oncology.

EORTC quality of life questionnaire to assess chemotherapy-induced peripheral neuropathy

The length of time from enrollment until the time of death (OS, overall survival

Fujian Cancer Hospital

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Apatinib

Protein Kinase Inhibitors

Enzyme Inhibitors

Apatinib (500 mg qd p.o.) plus POF until disease progression or intolerable toxicity or refused by the patients.

Apatinib (500 mg qd p.o.) until disease progression or intolerable toxicity or refused by the patients.

The POF regimen consisted of a 3-hour infusion of paclitaxel (135 mg/m2) followed by oxaliplatin (85 mg/m2) and Calcium Levofolinate (200 mg/m2).Subsequently, a 46-hour infusion of fluorouracil (2400 mg/m2) was administered using an ambulatory pump, repeating the cycle every 14 days.

Rongbo Lin

In previous studies,the investigators found that POF (A combination of oxaliplatin, fluorouracil and Paclitaxel) regimen appears to be of good efficacy and is well tolerated in patients with advanced gastric cancer. Apatinib is an orally antiangiogenic agent. It was approved and launched in China in 2014 as a 3rd-line treatment for patients with advanced gastric cancer. Therefore, investigators conducted the dose escalation phase I study to explore the safety of combination of apatinib and POF as first-line treatment for advanced gastric cancer. Now the investigators are going to start a phase 2 trial with apatinib 500mg + POF as second-line therapy to investigate the efficacy and safety in the patients with advanced gastric cancer.

Apatinib Combined With POF for Second-line Treatment of Gastric Adenocarcinoma

Phase II Study on the Second-line Treatment of Gastric Adenocarcinoma With Apatinib Combined With POF(Paclitaxel Plus Oxaliplatin Plus 5-fluorouracil Plus Leucovorin)

The length of time from enrollment until the time of progression of disease

The length of time from enrollment until the time of death

Symptoms and General Pathology

Neoplasm Metastasis

The aim of this study was to compare the efficacy and safety of intravenous or intraperitoneal paclitaxel plus FOLFOX as first-line treatment in AGC with peritoneal metastases, a phase II Clinical trial.

POF Versus FOLFOX Plus IP Paclitaxel in AGC

A Phase 2 Study of POF(Paclitaxel/Oxaliplatin/5-Fluorouracil/Leucovorin) Versus FOLFOX Plus Intraperitoneal Paclitaxel as a First-line Treatment in Advanced Gastric Cancer With Peritoneal Metastases

Adverse Event according to NCI CTCAE 5 criteria

Clinical response of treatment according to RESIST v1.1 criteria

Participants will receive apatinib in combination with POF,total 9-12 cycles.Then receive apatinib plus S-1 until pre-defined study end, disease progression, unacceptable toxicity, withdrawal of consent or death, whichever occurs first.

Participants will receive POF,total 9-12 cycles.Then receive S-1 until pre-defined study end, disease progression, unacceptable toxicity, withdrawal of consent or death, whichever occurs first.

This study is a randomized, parallel control, multicenter,phase II study, comparing the efficacy and safety of apatinib plus POF(paclitaxel plus oxaliplatin plus 5-fluorouracil plus leucovorin) versus POF, in the first-line treatment for patients with advanced/metastatic gastric cancer.

This is a randomized, two-arm, open-label, multicenter phase II trial. Our primary purpose is to compare that PFS rate at 6-month of patients with apatinib plus POF and POF for advanced/metastatic gastric cancer.

Eligible patients will randomized to a ratio of 1:1 to apatinib+POF (experimental group) or POF (control group). Stratification factors were 1) gender (male;female);2) previous surgical history (yes;no);3) metastatic sites (measurable; Immeasurable).

In treatment period, patients will be administrated POF, with or without apatinib, every 14 days for 1 cycle, total 9-12 cycles.After the above treatment finished,parients will received with S-1,with or without apatinib,every 21days for 1 cycle,until disease progression, toxicity intolerance, withdrawal of informed consent, patients judged must be terminated study termination.

The imaging evaluation was performed according to the RECIST 1.1 criteria every 6 weeks.

Study of the Apatinib Combine With POF Versus POF in Gastric Cancer

A Randomized,Parallel Controlled,Multicentre,Phase II Study of Apatinib Plus POF (Paclitaxel Plus Oxaliplatin Plus 5-fluorouracil Plus Leucovorin) Versus POF in Patients With Advanced/Metastatic Bastric Cancer

PFS was defined as the time from randomization to first documented disease progression (PD) using Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) or death from any cause, whichever occurred first. For target lesions, PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.PFS rate at 6-month defined from randomization to 6 month,the cases of patients documented no PD or death or not receive other anti-tumor treatment in percentage of evaluable patients

ORR was defined as percentage of participants with best (confirmed) overall response (BOR) of either CR or PR. ORR was assessed by the investigator according to RECIST version 1.1 and is based on BOR, which is defined as best response recorded from start of study treatment until disease progression/recurrence or death. Participants needed to have two consecutive assessments of PR or CR to be a responder. Only participants with measurable disease at baseline were included in the analysis of BOR and who did not have any evaluable post-baseline assessments were classified as not evaluable.

The ORR will be reported by percentage with each arms and appropriate confidence intervals.

Overall Survival (OS), defined as the time from the date of randomization to the date of death, regardless of the cause of death. Participants who were alive at the time of the analysis were censored at the date of the last follow-up assessment. Participants without follow-up assessment were censored at the day of last study medication and participants with no post-baseline information were censored at the date of randomization.

The OS will be will be estimated using Kaplan-Meier method. A Kaplan-Meier curve, median OS, hazard ratio with appropriate confidence intervals will be reported.

PFS was defined as the time from randomization to first documented disease progression (PD) using Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) or death from any cause, whichever occurred first. For target lesions, PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.

The PFS will be will be estimated using Kaplan-Meier method. A Kaplan-Meier curve, median PFS, hazard ratio with appropriate confidence intervals will be reported.

In previous studies, we found that POF (A combination of oxaliplatin, fluorouracil and Paclitaxel) regimen appears to be of good efficacy and is well tolerated in patients with advanced gastric cancer. Apatinib is an orally antiangiogenic agent. It was approved and launched in China in 2014 as a 3rd-line treatment for patients with advanced gastric cancer. Therefore, investigators conducted the dose escalation phase I study to explore the safety of combination of apatinib and POF as first-line treatment for advanced gastric cancer. Now we are going to start a phase 2 trial with apatinib 500mg + POF as first-line therapy to investigate the efficacy and safety in the patients with advanced gastric cancer.

Study of the Combination of Apatinib and POF

Phase II Study of the Combination of Apatinib and POF (Paclitaxel Plus Oxaliplatin Plus 5-fluorouracil Plus Leucovorin)

Antibodies

Immunoglobulins

Participants will receive camrelizumab in combination with apatinib plus POF until pre-defined study end, disease progression, unacceptable toxicity, withdrawal of consent or death, whichever occurs first.

Subjects receive SHR-1210 intravenously, Dosage form: lyophilised powder, Strength: 200 mg /vial，d1

Camrelizumab

Subjects receive Apatinib orally, Dosage form: tablet, Strength: 250 mg/tablet，TID

Apatinib Mesylate

rongbo Lin

This study is a single center, phase II study, to evaluate the effectiveness and safety of PD-1 Antibody(SHR-1210) Plus apatinib Combined With POF(paclitaxel plus oxaliplatin plus 5-fluorouracil plus leucovorin) , in the first-line treatment for patients with advanced/metastatic gastric cancer.

This is a exploratory, single-arm, open-label trial. The investigator's primary purpose is to compare that ORR of patients with camrelizumab plus apatinib and POF for advanced/metastatic gastric cancer.

In treatment period, patients will be administrated camrelizumab plus apatinib and POF, every 28 days for 1 cycle, until disease progression, toxicity intolerance, withdrawal of informed consent, patients judged must be terminated study termination.

The imaging evaluation was performed according to the RECIST 1.1 criteria every 8 weeks.

PD-1 Antibody(SHR-1210) Plus Apatinib Combined With POF in Advanced Gastric Cancer

PD-1 Antibody(SHR-1210) Plus Apatinib Combined With POF in Treatment Naive Advanced Gastric Cancer: A Phase II Study.

DCR was defined as percentage of participants with best (confirmed) overall response (BOR) of either CR or PR or SD. ORR was assessed by the investigator according to RECIST version 1.1 and is based on BOR, which is defined as best response recorded from start of study treatment until disease progression/recurrence or death. Participants needed to have two consecutive assessments of PR or CR or SD to be a responder. Only participants with measurable disease at baseline were included in the analysis of BOR and who did not have any evaluable post-baseline assessments were classified as not evaluable.

The ORR will be reported by percentage with each arms and appropriate confidence intervals.

Capecitabine

A 3-hour infusion of paclitaxel (135 mg/m2) followed by oxaliplatin (85 mg/m2) and leucovorin (400 mg/m2), administered simultaneously over a 2-hour infusion period. Subsequently, a 46-hour infusion of fluorouracil (2400 mg/m2) was administered using an ambulatory pump, repeating every 14 days for 12 cycles.

CAPOX: IV oxaliplatin given over 120 min at a dose of 130 mg/m2 on day 1, oral capecitabine 1000 mg/m2 twice daily on days 1 through 14 every 21 days for 8 cycles.

SOX: Oxaliplatin 130mg/m2 IV on D1 every 21 days and S-1 80mg/m2/day PO \[BSA \<1.25 40mg bid (total 80mg/day); BSA ≥1.25 - \<1.5 50mg bid (total 100mg/day); BSA ≥1.5 60mg bid (total 120mg/day)\], divided by two on D1-14 every 21 days for 8 cycles.

mFOLFOX6: IV oxaliplatin given over 120 min at a dose of 85 mg/m2 on day 1 followed by IV leucovorin 400 mg/m2 over 2h, IV bolus 5-Fluorouracil 400 mg/m2 and IV infusional 5-Fluorouracil 2400 mg/m2 over 46h every 14 days for 12 cycles.

CAPOX/SOX/FOLFOX

FNF-014 is a randomised, open-label, multicentre, parallel-group, phase 3 study in China to prove superiority of POF over S-1/docetaxel in postoperative adjuvant setting for pStage III gastric adenocarcinoma (including adenocarcinoma of the gastrooesophageal junction).

A Randomized Phase III Study Comparing POF With SOX/CAPOX/FOLFOX as a Postoperative Adjuvant Chemotherapy for Curatively Resected Stage III Gastric Cancer

A Randomized Phase III Study Comparing POF (Paclitaxel/Oxaliplatin/Leucovorin/5-FU) With SOX/CAPOX/FOLFOX as a Postoperative Adjuvant Chemotherapy for Curatively Resected Stage III Gastric Cancer

The time from randomisation to the time of recurrence of the original gastric cancer, development of a new gastric cancer, or death from any cause

The time from the date of randomisation to date of death from any cause

The incidence of chemotherapy related adverse events

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
POF Versus FOLFOX Versus FOLFOX Plus ip Paclitaxel in AGC	NCT02845908	Malignant Neopl...	POF FOLFOX FOLFOX plus PAC...	18 Years - 75 Years	Fujian Cancer Hospital
Apatinib Combined With POF for Second-line Treatment of Gastric Adenocarcinoma	NCT03788174	Gastric Adenoca...	Apatinib POF	18 Years - 70 Years	Fujian Cancer Hospital
POF Versus FOLFOX Plus IP Paclitaxel in AGC	NCT04155671	Gastric Cancer	POF FOLFOX plus PAC...	18 Years - 75 Years	Fujian Cancer Hospital
Study of the Apatinib Combine With POF Versus POF in Gastric Cancer	NCT04121039	Gastric Adenoca... Advanced Cancer	Apatinib POF	18 Years - 75 Years	Fujian Cancer Hospital
Study of the Combination of Apatinib and POF	NCT03707639	Gastric Adenoca...	Apatinib POF	18 Years - 70 Years	Fujian Cancer Hospital
PD-1 Antibody(SHR-1210) Plus Apatinib Combined With POF in Advanced Gastric Cancer	NCT04174339	Advanced Gastri...	Camrelizumab Apatinib Mesyla... POF	18 Years - 70 Years	Fujian Cancer Hospital
Study of the Apatinib Combine With POF Versus POF in Gastric Cancer	NCT04121039	Gastric Adenoca... Advanced Cancer	Apatinib POF	18 Years - 75 Years	Fujian Cancer Hospital
Study of the Combination of Apatinib and POF	NCT03707639	Gastric Adenoca...	Apatinib POF	18 Years - 70 Years	Fujian Cancer Hospital
POF Versus FOLFOX Versus FOLFOX Plus ip Paclitaxel in AGC	NCT02845908	Malignant Neopl...	POF FOLFOX FOLFOX plus PAC...	18 Years - 75 Years	Fujian Cancer Hospital
PD-1 Antibody(SHR-1210) Plus Apatinib Combined With POF in Advanced Gastric Cancer	NCT04174339	Advanced Gastri...	Camrelizumab Apatinib Mesyla... POF	18 Years - 70 Years	Fujian Cancer Hospital
A Randomized Phase III Study Comparing POF With SOX/CAPOX/FOLFOX as a Postoperative Adjuvant Chemotherapy for Curatively Resected Stage III Gastric Cancer	NCT03788226	Gastric Cancer ...	POF CAPOX/SOX/FOLFO...	18 Years - 70 Years	Fujian Cancer Hospital
Study of the Combination of Apatinib and POF	NCT03707639	Gastric Adenoca...	Apatinib POF	18 Years - 70 Years	Fujian Cancer Hospital

Spots Global Cancer Trial Database for pof

Every month we try and update this database with for pof cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for pof

Every month we try and update this database with for pof cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for pof cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.